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CompletedNCT04998955Updated Aug 10, 2021

MST in Patients With Inflammatory Rheumatic Disease

An interventional study of Maximal strength training in Inflammatory Rheumatism, sponsored by Molde University College. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.

Sponsored by Molde University College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Oct 2018, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Inflammatory Rheumatism

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Keywords

  • Maximal strength
  • Quality of life
  • Heavy resistance training
  • Rate of force development
  • Rehabilitation
03

In context

Rheumatic Fever

55 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.

This study's enrollment of 24 is below the median of 70 across 28 interventional studies indexed under Rheumatic Fever.

Browse Rheumatic Fever studies →

Lead sponsor

Molde University College is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Inflammatory rheumatic disease

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    MST group

    Exercise intervention, 20 supervised MST sessions

    Behavioral: Maximal strength training

  • No intervention
    Control group

    IRD patient controls

Interventions

  • BehavioralMaximal strength training

    Exercise intervention utilizing 4 x 4 repetitions heavy resistance training

06

What researchers measure

Primary outcomes

  1. Change in physiological measure assesed in the horizontal leg press apparatus

    Maximal strength; one repetition maximum (measured in kg)

    Time frame: At baseline and after 10 weeks.

Secondary outcomes

  1. 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

    Time frame: At baseline and after 10 weeks

07

Study locations

1 site
  • Myworkout - Medical Rehabilitation Clinic
    Trondheim, Please Select 7047, Norway
08

References and documents

Publications

  • 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. PubMed 35438424 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Dec 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2021
First posted
Aug 10, 2021
StartActual
Oct 1, 2018
Primary completionActual
Dec 21, 2018
CompletionActual
Dec 21, 2018
Last update
Aug 10, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04998955
Lead sponsor
Molde University College
Responsible party
Sponsor
First posted
Aug 10, 2021
Start date
Oct 1, 2018
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018
Last update
Aug 10, 2021

Study contacts

Jan Helgerud, PhD
principal investigator · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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