MST in Patients With Inflammatory Rheumatic Disease

Sponsor

Molde University College (Other)

Overall Status

Completed

CT.gov ID

NCT04998955

Collaborator

(none)

Enrollment

Location

Arms

2.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the feasibility of 10 weeks of maximal strength training (MST) in patients with inflammatory rheumatic disease. As well as the effects of MST on maximal strength, rate of force developement and quality of life in this patient population.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Rheumatism	Behavioral: Maximal strength training	N/A

Detailed Description

Patients with inflammatory rheumatic diseases (IRD) such as rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus have reduced strength and muscle mass in the lower extremities compared to healthy control groups. This attenuation results in impaired physical function and health-related quality-of-life. Maximum muscle strength is an important indicator of total mortality, even when adjusted for cardiovascular health. Therefore, international guidelines encourage strength training since it has been demonstrated that resistance exercise using moderate loads (≤80% of one repetition maximum; 1RM) result in improved strength and function without worsening pain or disease activity.

In this trial patients are randomized into either a maximal strength training (MST) intervention group or a control group. The intervention period will last 10 weeks. The MST group will perform two supervised MST sessions per week, on non-consecutive days, in a seated horizontal leg press apparatus. The control group will continue with their existing activity routines. One MST session consist of 4 series of 4 repetitions maximum (4RM) utilizing heavy loads (~90 % of 1RM), separated by 3 minutes break and lasts approximately 15-20 minutes. The MST intervention follows the principle of linear progression continuously adjusting the resistance to achieve the targeted 4RM training load. The control group will be given supervised introduction to effective strength training after the intervention period.

The purpose of this intervention is to evaluate the feasibility of the highly potent MST intervention and its impact on 1RM, rate of force development (RFD) and quality of life in the IRD patient population. MST has been documented to yield almost twice the increase in both 1RM and RFD as conventional strength training performed with moderate resistance. However, it is uncertain if MST is well tolerated by the IRD patient population which is characterized by having pain, stiffness, and joint swelling. Before and after the training period, identical testing (approximately 60 min) will be performed by both intervention groups. The testing will include measurements of maximal oxygen uptake in an endurance test as well as maximal muscle strength, recorded as 1RM, and dynamic RFD both carried out in a horizontal leg press apparatus. Additionally, quality of life questionnaires will be obtained.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcome assessor was blinded with regards to which intervention group the participants had been assigned.

Primary Purpose:

Treatment

Official Title:

Maximal Strength Training in Patients With Inflammatory Rheumatic Disease: Implications for Physical Function and Quality of Life

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Dec 21, 2018

Actual Study Completion Date :

Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MST group Exercise intervention, 20 supervised MST sessions	Behavioral: Maximal strength training Exercise intervention utilizing 4 x 4 repetitions heavy resistance training
No Intervention: Control group IRD patient controls

Arm

Intervention/Treatment

Experimental: MST group

Exercise intervention, 20 supervised MST sessions

Behavioral: Maximal strength training

Exercise intervention utilizing 4 x 4 repetitions heavy resistance training

No Intervention: Control group

IRD patient controls

Outcome Measures

Primary Outcome Measures

Change in physiological measure assesed in the horizontal leg press apparatus [At baseline and after 10 weeks.]
Maximal strength; one repetition maximum (measured in kg)

Secondary Outcome Measures

Change in health-related quality of life assessed by Norwegian RAND-36 [At baseline and after 10 weeks]
Questionnaire scoring on a 0-100 scale with higher scores identifying better outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inflammatory rheumatic disease

Exclusion Criteria:

Inability to complete the testing procedures
Pregnancy
Not able to perform exercise intervention
Planed surgeries or other plans during initial exercise intervention period than directly will effect the testing or training.
unstable ischemic heart disease
unstable aortic stenosis or aneurysm
Less than 80% compliance of planned training sessions