PBFR2: Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis

• Sponsor: University of Iowa (Other)
• Overall Status: Completed
• CT.gov ID: NCT01440972
• Collaborator: The American Geriatrics Society (Other)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 22.5

Study Details

Study Description

Brief Summary

The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators will test the following hypotheses. In comparison with low-intensity resistance training without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:

Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee extensor strength

Secondary Hypotheses:

1. Increase quadriceps muscle volume assessed by MRI

2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb

3. Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Symptomatic Knee Osteoarthritis	Other: partial blood flow restriction (PBFR); Other: low intensity resistance training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Official Title: Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exercise without PBFR	Other: low intensity resistance training; low intensity resistance training without partial blood flow restriction
Experimental: exercise with PBFR	Other: partial blood flow restriction (PBFR); low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass [4 weeks]

Secondary Outcome Measures

1. Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging [4 weeks]

2. Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum [4 weeks]

3. Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale [4 weeks]

   KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.

4. Change in Isokinetic Knee Extensor Strength [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female

• Age 45-65

• BMI greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis

Exclusion Criteria:

• Resistance training at any time in the last 3 months prior to study

• Bilateral knee replacement

• Lower limb amputation

• Lower limb surgery in the last 6 months that affects walking ability or ability to exercise

• Back, hip or knee problems that affect walking ability or ability to exercise

• Unable to walk without a cane or walker

• Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica

• Multiple sclerosis

• Known neuropathy

• Self-report of Diabetes

• Currently being treated for cancer or having untreated cancer

• Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)

• Peripheral Vascular Disease

• History of myocardial infarction or stroke in the last year

• History of deep venous thrombosis

• Chest pain during exercise or at rest

• Use of supplemental oxygen

• Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)

• Staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity)

• Concurrent study participation (such as the MOST study)

• Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa
• The American Geriatrics Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neil A Segal, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT01440972
• Other Study ID Numbers: 201109738
• First Posted: Sep 27, 2011
• Last Update Posted: Dec 5, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Neil A Segal, Associate Professor, University of Iowa: knee osteoarthritis; symptomatic knee osteoarthritis; isotonic leg-press strength; isokinetic knee extensor strength; quadriceps volume
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Period Title: Overall Study
STARTED	24	21
COMPLETED	21	19
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR	Total
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.	Total of all reporting groups
Overall Participants	21	19	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.6 (6.9)	56.1 (5.9)	55.4 (6.5)
Gender (Count of Participants)
Female	21 100%	19 100%	40 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Measure Participants	21	19
Mean (Standard Deviation) [kg per kg body mass]	0.2 (0.3)	0.4 (0.3)

2. Secondary Outcome

Title	Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Measure Participants	21	19
Mean (Standard Deviation) [Percent change]	0.01 (.73)	1.3 (0.80)

3. Secondary Outcome

Title	Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Measure Participants	21	19
Mean (Standard Deviation) [Watts]	0.42 (.26)	.62 (.27)

4. Secondary Outcome

Title	Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale
Description	KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Measure Participants	21	19
Mean (Standard Deviation) [units on a scale]	1.8 (2.7)	2.0 (2.8)

5. Secondary Outcome

Title	Change in Isokinetic Knee Extensor Strength
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Without PBFR	Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction	partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Measure Participants	21	19
Least Squares Mean (Standard Error) [Nm/kg]	-0.05 (0.03)	.07 (.03)

Adverse Events

Arm/Group Title	Exercise Without PBFR		Exercise With PBFR
Arm/Group Description	low intensity resistance training: low intensity resistance training without partial blood flow restriction		partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
All Cause Mortality
	Exercise Without PBFR		Exercise With PBFR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exercise Without PBFR		Exercise With PBFR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Exercise Without PBFR		Exercise With PBFR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.