NCT04998955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

July 12, 2021

Last Update Submit

August 3, 2021

Conditions

Keywords

Maximal strengthQuality of lifeHeavy resistance trainingRate of force developmentRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in physiological measure assesed in the horizontal leg press apparatus

    Maximal strength; one repetition maximum (measured in kg)

    At baseline and after 10 weeks.

Secondary Outcomes (1)

  • Change in health-related quality of life assessed by Norwegian RAND-36

    At baseline and after 10 weeks

Study Arms (2)

MST group

EXPERIMENTAL

Exercise intervention, 20 supervised MST sessions

Behavioral: Maximal strength training

Control group

NO INTERVENTION

IRD patient controls

Interventions

Exercise intervention utilizing 4 x 4 repetitions heavy resistance training

MST group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inflammatory rheumatic disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Myworkout - Medical Rehabilitation Clinic

Trondheim, Please Select, 7047, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jan Helgerud, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was blinded with regards to which intervention group the participants had been assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

August 10, 2021

Study Start

October 1, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations