Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04998955 |
| Other study ID # |
HHRevma2 - MST |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
December 21, 2018 |
Study information
| Verified date |
August 2021 |
| Source |
Molde University College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
