Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01307787
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of a group-based exercise and educational program for people with Rheumatoid Arthritis (RA) on physical performance and disease-self-management.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: experimental Fit-program; Other: no intervention	N/A

Detailed Description

Currently, the effectiveness of a program consisting of education to improve disease self-management combined with intensive exercises is not clear. In the present study the investigators developed a group-based program for people with RA consisting of physical exercise to increase physical performance (i.e. aerobic capacity and muscle strength) combined with an educational program to improve disease self-management (self-reported health status and self-efficacy). The investigators called it the 'FIT program'. The aim of the present randomized controlled trial (RCT) was to examine the effects of the FIT program on aerobic capacity, muscle strength, self-reported health status and self-efficacy, in a population of people with RA. The investigators hypothesized that the FIT-program would have beneficial effects on physical performance (ie. aerobic capacity and muscle strength) and disease self-management (i.e. perceived health status and self-efficacy components) compared to a waiting list control group (WLCgroup).

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effects of a Group-based Exercise and Educational Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis: a Randomized Controlled Study
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fit-program Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.	Other: experimental Fit-program; Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part consisted of a muscle exercise circuit and bicycle training,sport and aqua jogging. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level. Further information was given about body sensations, sports, food and energy, pain, fatigue, emotional changes, sleeping disturbance and daily routine.; Other Names: rehabilitation
Other: waiting list control group The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.	Other: no intervention; waiting list control group with no intervention; Other Names: rehabilitation

Outcome Measures

Primary Outcome Measures

1. Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness [baseline, postintervention at 9 weeks]

   maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants'weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from < 21( sedentary with disease) to > 57 ( very good physical condition).

Secondary Outcome Measures

1. Change in Self-efficacy Pain and Other Symptoms [baseline, postintervention at 9 weeks,]

   Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.

2. Change in Self-efficacy Function [baseline, postintervention at 9 weeks,]

   Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.

3. Change in Muscle Strength of the Upper Extremity [baseline, postintervention at 9 weeks,]

   Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.

4. Change in Muscle Strength of the Lower Extremity [baseline, postintervention at 9 weeks,]

   Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.

5. Change in Health Status: Physical Health [baseline, postintervention at 9 weeks,]

   Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.

6. Change in Health Status: Psychological Health [baseline, postintervention at 9 weeks,]

   Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.

7. Change in Health Status: Social Interaction [baseline, postintervention at 9 weeks,]

   Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 66 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• medical diagnosis of RA according to the American College of Rheumatology (ACR) criteria

• between 18 and 66 years of age

Exclusion Criteria:

• severe disease activity (Disease Activity Score:DAS-28 > 5.1)

• cardiac or pulmonary diseases resulting in restrictions in their ability to follow a physical exercise program

• a Steinbrocker classification of functional capacity in RA ≥ 3

• no stable medication for the RA

• intra-articular injections during the time of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen, Center for Rehabilitation	Haren	Groningen	Netherlands	PO box 30 002

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

• Principal Investigator: Ellen van Weert, phd, UMCG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01307787
• Other Study ID Numbers: 210.076
• First Posted: Mar 3, 2011
• Last Update Posted: Jan 28, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by , ,: exercise; education; self-management; rehabilitation
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Recruitment Details	A Rheumatologist referred people diagnosed with RA to the rehabilitation department if they had complaints concerning their physical performance or if they experienced problems with the daily management of their illness. Referred participants were independent and living at home. They did not include residents of nursing homes.
Pre-assignment Detail	A total of thirty-nine individuals were referred for this study. Thirty-four individuals returned a signed Informed Consent form and five decided not to participate for a variety of reasons.(Impairment due to trauma n = 1 Not able to follow the program n = 1 Personal reasons n = 3)

Arm/Group Title	Fit-program	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level.	The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
Period Title: Overall Study
STARTED	19	15
T1= After 9 Weeks Post Intervention	18	15
T2= After 22 Weeks at Follow-up	17	15
COMPLETED	17	15
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Fit-program	Waiting List Control Group	Total
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level.	The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.	Total of all reporting groups
Overall Participants	19	15	34
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 100%	15 100%	34 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (11.9)	51.8 (9.4)	48 (11.3)
Sex: Female, Male (Count of Participants)
Female	12 63.2%	12 80%	24 70.6%
Male	7 36.8%	3 20%	10 29.4%
Region of Enrollment (participants) [Number]
Netherlands	19 100%	15 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
Description	maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants'weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from < 21( sedentary with disease) to > 57 ( very good physical condition).
Time Frame	baseline, postintervention at 9 weeks

Outcome Measure Data

Analysis Population Description

Some VO2 max data (n=4 in the intervention group and n=2 in the WLC group)could not be collected because of specific participant conditions at different testing time points. 4 subjects did not reach the necessary heart rate to estimate the VO2 max. One subject had hypertension and one subject had knee problems.

Arm/Group Title	Intervention Fit Program	Waiting List Control Group
Arm/Group Description	An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.	No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
Measure Participants	15	13
Mean (Standard Deviation) [ml/min/kg]	3.82 (3.86)	-0.44 (2.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Change in Self-efficacy Pain and Other Symptoms
Description	Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

per protocol 2 subjects( n=2) in the intervention fitprogram withdrew from the study

Arm/Group Title	Intervention Fit Program	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.	no intervention. WLC was allowed to follow the program after the study.
Measure Participants	17	15
Mean (Standard Deviation) [units on a scale]	0.42 (0.71)	0.28 (0.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Change in Self-efficacy Function
Description	Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

analysis per protocol, 2 subjects(n=2) in the intervention fitprogram withdrew from the study.

Arm/Group Title	Intervention Fitprogram Group	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.	no intervention, allowed to follow the program after the study
Measure Participants	17	15
Mean (Standard Deviation) [units on a scale]	0.29 (0.57)	0.10 (0.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Change in Muscle Strength of the Upper Extremity
Description	Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

per protocol, one subject (n=1) in the intervention fitprogram withdrew from the study.

Arm/Group Title	Intervention Fitprogram Group	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component	no intervention, allowed to follow the program after the study
Measure Participants	18	15
Mean (Standard Deviation) [newton]	36.06 (121.71)	-5.49 (96.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Change in Muscle Strength of the Lower Extremity
Description	Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

per protocol,Lower extremity(LE) muscle strength data for one participant(n=1) in the WLC group is missing because knee problems prevented testing.

Arm/Group Title	Intervention Fitprogram Group	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component	no intervention, allowed to follow the program after the study
Measure Participants	18	14
Mean (Standard Deviation) [newton]	111.20 (184.82)	25.61 (189.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Change in Health Status: Physical Health
Description	Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.

Arm/Group Title	Intervention Fitprogram Group	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component	no intervention, allowed to follow the program after the study
Measure Participants	17	15
Mean (Standard Deviation) [units on a scale]	-0.68 (1.00)	-0.14 (0.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Change in Health Status: Psychological Health
Description	Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

analysis per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.

Arm/Group Title	Intervention Fitprogram Group	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component	no intervention, allowed to follow the program after the study
Measure Participants	17	15
Mean (Standard Deviation) [units on a scale]	-0.34 (1.11)	0.08 (1.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Change in Health Status: Social Interaction
Description	Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.
Time Frame	baseline, postintervention at 9 weeks,

Outcome Measure Data

Analysis Population Description

per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.

Arm/Group Title	Intervention Fitprogram Group	Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component	no intervention, allowed to follow the program after the study
Measure Participants	17	15
Mean (Standard Deviation) [units on a scale]	-0.48 (1.90)	-0.88 (2.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Fit Program, Waiting List Control Group
	Comments	Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Adverse Event Reporting Description	serious and other non-serious adverse events were not collected/assessed.
Arm/Group Title	Fit-program		Waiting List Control Group
Arm/Group Description	Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level.		The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
All Cause Mortality
	Fit-program		Waiting List Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fit-program		Waiting List Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Fit-program		Waiting List Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

An important limitation in our study was the low number of participants included in both groups which may have induced a lack of power.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.