NCT07073911

Brief Summary

This will be a clinical trial of a standardized group exercise intervention, Les Mills Thrive, and determine if it alters muscle activation patterns and improves strength, balance, and symptoms in those with knee osteoarthritis (OA). Muscle activation patterns will be assessed using surface electromyography, strength will be assessed using isokinetic dynamometry, balance will be measured using the Community Balance and Mobility Scale (CB\&M), and symptoms and typical activity will be measured using two questionnaires: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Physical Activity Scale for the Elderly (PASE). These outcome measures will be measured at baseline and after a 12-week group exercise intervention (Les Mills Thrive) for 42 older adults with knee OA. Results of this study will be disseminated via a report to Les Mills International, in community presentations, at relevant academic (e.g. Osteoarthritis Research Society International (OARSI) annual conference) and industry (e.g. Medical Fitness Association annual meeting) conferences, in an academic journal publication (e.g. Arthritis Care \& Research), and through press releases or other media publications.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress86%
Aug 2025Jun 2026

First Submitted

Initial submission to the registry

July 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 26, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

July 16, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

muscle activitygaitbalancestrength

Outcome Measures

Primary Outcomes (4)

  • Quadriceps amplitude (Quadriceps PC1)

    Surface electromyography (EMG) will be used to assess muscle activation patterns from the quadriceps and hamstrings. We will assess overall magnitude of activity as well as co-activation. These outcomes will be extracted from the EMG data using principal component analysis (PCA). PCA is a pattern recognition technique that extracts the main patterns in waveform data. It has previously identified patterns of quadriceps and hamstrings activity that are correlated with knee osteoarthritis progression. The first pattern extracted from quadriceps EMG waveforms (Quadriceps PC1) captures the overall magnitude (i.e. amplitude) of quadriceps activity.

    From initial data collection to the end of treatment at 12 weeks

  • Quadriceps co-activation ( Quadriceps PC2)

    Surface electromyography (EMG) will be used to assess muscle activation patterns from the quadriceps and hamstrings. We will assess overall magnitude of activity as well as co-activation. These outcomes will be extracted from the EMG data using principal component analysis (PCA). PCA is a pattern recognition technique that extracts the main patterns in waveform data. It has previously identified patterns of quadriceps and hamstrings activity that are correlated with knee osteoarthritis progression. The second pattern extracted from quadriceps EMG waveforms (Quadriceps PC2) captures prolonged quadriceps activity (i.e. co-activation).

    From baseline data collection to the end of the intervention at 12 weeks.

  • Hamstrings amplitude (Hamstrings PC1)

    Surface electromyography (EMG) will be used to assess muscle activation patterns from the quadriceps and hamstrings. We will assess overall magnitude of activity as well as co-activation. These outcomes will be extracted from the EMG data using principal component analysis (PCA). PCA is a pattern recognition technique that extracts the main patterns in waveform data. It has previously identified patterns of quadriceps and hamstrings activity that are correlated with knee osteoarthritis progression. The first pattern extracted from hamstrings EMG waveforms (Hamstrings PC1) captures the overall magnitude (i.e. amplitude) of hamstrings activity.

    From baseline data collection to the end of the intervention at 12 weeks.

  • Hamstrings co-activation (Hamstrings PC2)

    Surface electromyography (EMG) will be used to assess muscle activation patterns from the quadriceps and hamstrings. We will assess overall magnitude of activity as well as co-activation. These outcomes will be extracted from the EMG data using principal component analysis (PCA). PCA is a pattern recognition technique that extracts the main patterns in waveform data. It has previously identified patterns of quadriceps and hamstrings activity that are correlated with knee osteoarthritis progression. The second pattern extracted from hamstrings EMG waveforms (Hamstrings PC2) captures prolonged hamstrings activation (i.e. co-activation).

    From baseline data collection to the end of the intervention at 12 weeks.

Secondary Outcomes (5)

  • Balance (Community Balance & Mobility Scale)

    From baseline data collection to the end of the intervention at 12 weeks.

  • Knee extensor strength

    From baseline data collection until the end of the intervention at 12 weeks.

  • Knee flexor strength

    From baseline data collection until after the 12 week intervention.

  • Symptoms (WOMAC)

    From baseline data collection until after the 12 week intervention.

  • Physical activity

    From baseline until after the 12 week intervention.

Study Arms (1)

Exercise program

EXPERIMENTAL

Les Mills Thrive is a 45-minute class that consists of flexibility, strength, and coordination exercises designed to be delivered in a group fitness environment. Participants will have the option to attend group fitness classes in person, or do the exercise program at home on their own asynchronously, using recorded classes as guidance.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Les Mills Thrive is a 45-minute class that consists of flexibility, strength, and coordination exercises. This program aims to improve sensorimotor control and strength via functional weight-bearing exercises and floor exercises to isolate targeted hip and core muscles. In each class (whether in person or online), a certified Les Mills Thrive instructor will provide options to either increase or decrease the intensity of each exercise to cater to varying fitness levels and fluctuating symptoms. Each exercise has an assisted (using a chair for balance), body weight, and resisted (weight or exercise tubing) option. Participants will have the option to attend group fitness classes or do the classes asynchronously at home using a link to access a recorded class.

Also known as: Les Mills Thrive
Exercise program

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have received a diagnosis of knee OA from a physician and/or meet the American College of Rheumatology Clinical Classification Criteria for Osteoarthritis of the knee. The American College of Rheumatology criteria specify that a participant needs to have pain and fulfill three of the following six items: 1) aged 50 years or older, 2) no early morning stiffness or morning stiffness less than 30 minutes, 3) crepitus, 4) bony tenderness, 5) bony enlargement, 6) no palpable warmth
  • They must pass the Get Active Questionnaire to ensure that they are safe to begin an exercise program (determined via recruitment email).

You may not qualify if:

  • i) severe knee trauma, knee surgery, or intraarticular knee joint injections in the previous six months, ii) active synovitis, iii) concurrent neurological (i.e. Parkinson's disease, Alzheimer's dementia, or polyneuropathy), endocrine (i.e., diabetes mellitus) and/or vestibular disorders which may affect balance, iv) chronic disease that may put them at risk during the exercise classes (i.e., history of heart failure, stroke, chronic obstructive lung disease), v) uncorrected visual impairment which may affect balance, or vi) an inflammatory rheumatic disease (i.e., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic reactive arthritis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Fraser Valley

Chilliwack, British Columbia, V2R0N3, Canada

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gillian Hatfield, PhD

    University of the Fraser Valley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 20, 2025

Study Start

August 26, 2025

Primary Completion (Estimated)

June 19, 2026

Study Completion (Estimated)

June 19, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Primary and secondary outcome measures: EMG data, balance scores, WOMAC scores, knee extensor and flexor strength, PASE scores Also participant age, sex, gender

Shared Documents
ICF
Time Frame
Approximately June 2026 until June 2031 (five years).
Access Criteria
Academics at other universities will be able to access the data by contacting the Primary Investigator via email.

Locations