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MST in Patients With Inflammatory Rheumatic Disease

Primary Purpose

Inflammatory Rheumatism

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Maximal strength training
Sponsored by
Molde University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Rheumatism focused on measuring Maximal strength, Quality of life, Heavy resistance training, Rate of force development, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Myworkout - Medical Rehabilitation Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MST group

Control group

Arm Description

Exercise intervention, 20 supervised MST sessions

IRD patient controls

Outcomes

Primary Outcome Measures

Change in physiological measure assesed in the horizontal leg press apparatus
Maximal strength; one repetition maximum (measured in kg)

Secondary Outcome Measures

Change in health-related quality of life assessed by Norwegian RAND-36
Questionnaire scoring on a 0-100 scale with higher scores identifying better outcomes

Full Information

First Posted
July 12, 2021
Last Updated
August 3, 2021
Sponsor
Molde University College
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1. Study Identification

Unique Protocol Identification Number
NCT04998955
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molde University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Rheumatism
Keywords
Maximal strength, Quality of life, Heavy resistance training, Rate of force development, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The outcome assessor was blinded with regards to which intervention group the participants had been assigned.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MST group
Arm Type
Experimental
Arm Description
Exercise intervention, 20 supervised MST sessions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
IRD patient controls
Intervention Type
Behavioral
Intervention Name(s)
Maximal strength training
Intervention Description
Exercise intervention utilizing 4 x 4 repetitions heavy resistance training
Primary Outcome Measure Information:
Title
Change in physiological measure assesed in the horizontal leg press apparatus
Description
Maximal strength; one repetition maximum (measured in kg)
Time Frame
At baseline and after 10 weeks.
Secondary Outcome Measure Information:
Title
Change in health-related quality of life assessed by Norwegian RAND-36
Description
Questionnaire scoring on a 0-100 scale with higher scores identifying better outcomes
Time Frame
At baseline and after 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Helgerud, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myworkout - Medical Rehabilitation Clinic
City
Trondheim
State/Province
Please Select
ZIP/Postal Code
7047
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35438424
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.
Results Reference
derived

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MST in Patients With Inflammatory Rheumatic Disease

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