Group-based Exercise Training Programs for Military Members With Musculoskeletal Conditions
1 other identifier
interventional
120
1 country
1
Brief Summary
This randomized controlled trial will compare the mid- and long-term effects of group-based training programs with usual individual physiotherapy care for the treatment of musculoskeletal disorders in military. One hundred and twenty soldiers presenting one of the four targeted musculoskeletal disorders (low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain) will be recruited and randomly assigned to either a 12-weeks group-based training program or 12-weeks usual individual physiotherapy care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
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
First Submitted
Initial submission to the registry
January 28, 2022
CompletedStudy Start
First participant enrolled
January 28, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedMarch 2, 2022
March 1, 2022
1.3 years
January 28, 2022
March 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Functional limitations
Pain-related functional limitations will be measured with the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Interference subscale is recommended for assessment of pain-related functional limitations and includes seven items that measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
Week 26
Secondary Outcomes (25)
Functional limitations
Week 6 (mid-intervention)
Functional limitations
Week 12 (end of intervention)
Pain severity
Week 6 (mid-intervention)
Pain severity
Week 12 (end of intervention)
Pain severity
Week 26
- +20 more secondary outcomes
Study Arms (2)
Usual individual physiotherapy care
ACTIVE COMPARATORParticipants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received usual/individual physiotherapy care over a period of 12-weeks for the treatment of their musculoskeletal conditions if randomized in this group.
Group-supervised physiotherapy training programs
EXPERIMENTALParticipants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received group-supervised physiotherapy training programs over a period of 12-weeks for the treatment of their musculoskeletal condition if randomized in this group.
Interventions
Usual and individual physiotherapy care guidelines were developed through a round-table discussion involving experts in musculoskeletal health. From the round-table discussion, the consensus as reflecting best-practices for the rehabilitation of musculoskeletal rehabilitation supported an active exercise rehabilitation approach which includes strengthening and neuromuscular training exercises. Furthermore, the following treatments are considered in addition to active exercises: * Range of motion: active, active-assisted, passive, repeated movements (Mulligan or McKenzie); * Stretching / manual therapy: mobilizations, manipulation, neural mobility, active release therapy; * Individual proprioceptive training.
Three group-supervised physiotherapy training programs (The lumbar, the upper extremity and the lower extremity training programs) were developed for military members with musculoskeletal conditions. They are composed of stations that each include several exercises of varying levels of difficulty. Group size will vary between 5 to 20 participants for one physiotherapist, and each military member performs his/her own exercises. During a typical session, the participant and therapist will choose one exercise to perform per station according to two main criteria: severity of the condition and the ability to perform the exercises optimally. The level of supervision is adapted to the participant's needs and performance. Progression in the programs leads to the execution of exercises that simulate functional and occupational tasks.
Eligibility Criteria
You may qualify if:
- Aged between 18-60 years
- Present one of the four targeted musculoskeletal disorders:
- Low back pain:
- Patellofemoral pain syndrome:
- Rotator cuff-related shoulder pain:
- Lateral ankle sprain:
You may not qualify if:
- Are unavailable to participate in a 12-week intervention;
- Have a diagnosis of rheumatoid, inflammatory, neurological or neurodegenerative disease;
- Received a corticosteroid injection in the previous 6 weeks in the affected region;
- Have had more than 6 months of work restriction for their current musculoskeletal pain;
- Acute conditions (Constant and intense pain \[\>5/10\];Severely limited range of motion \[more than 50% in at least 2 directions\]; Obvious lateral shift for low back pain or Unable to bear weight \[for lateral ankle sprain\])
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Laval University
Québec, G1V 0A6, Canada
Related Publications (1)
Dupuis F, Perreault K, Hebert LJ, Perron M, Fredette MA, Desmeules F, Roy JS. Group-based exercice training programs for military members presenting musculoskeletal disorders - protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2022 Apr 18;23(1):366. doi: 10.1186/s12891-022-05317-6.
PMID: 35436907DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Sébastien Roy, PT, PhD
Laval University, Quebec, Qc (Canada)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The research assistant and treating therapist will be blinded to baseline evaluation results. Given that for this type of intervention it is impossible to blind the treating physiotherapists and participants, only the investigator, evaluator and statistician will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 28, 2022
First Posted
February 11, 2022
Study Start
January 28, 2022
Primary Completion
April 30, 2023
Study Completion
August 31, 2023
Last Updated
March 2, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share