MST in Patients With Inflammatory Rheumatic Disease

August 3, 2021 updated by: Molde University College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Please Select
      • Trondheim, Please Select, Norway, 7047
        • Myworkout - Medical Rehabilitation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physiological measure assesed in the horizontal leg press apparatus
Time Frame: At baseline and after 10 weeks.
Maximal strength; one repetition maximum (measured in kg)
At baseline and after 10 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molde University College

Investigators

  • Principal Investigator: Jan Helgerud, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 21, 2018

Study Completion (Actual)

December 21, 2018

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHRevma2 - MST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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