Clinical trial NCT04998955: MST in Patients With Inflammatory Rheumatic Disease
Official title: Maximal Strength Training in Patients With Inflammatory Rheumatic Disease: Implications for Physical Function and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Rheumatism
Keywords: Maximal strength
Quality of life
Heavy resistance training
Rate of force development
Rehabilitation
Lead sponsor: Molde University College
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physiological measure assesed in the horizontal leg press apparatus
timeFrame: At baseline and after 10 weeks.
Secondary outcomes:
measure: Change in health-related quality of life assessed by Norwegian RAND-36
timeFrame: At baseline and after 10 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Myworkout - Medical Rehabilitation Clinic
state: Please Select
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jan Helgerud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haglo H, Berg OK, Hoff J, Helgerud J, Wang E. Maximal strength training in patients with inflammatory rheumatic disease: implications for physical function and quality of life. Eur J Appl Physiol. 2022 Jul;122(7):1671-1681. doi: 10.1007/s00421-022-04948-w. Epub 2022 Apr 19.