NCT05666167

Brief Summary

The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress79%
Apr 2023Mar 2027

First Submitted

Initial submission to the registry

November 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

November 17, 2022

Last Update Submit

April 7, 2026

Conditions

Keywords

osteoarthritisexercise maintenancetelehealthgroup exercisetext messaging

Outcome Measures

Primary Outcomes (3)

  • Number of Referrals

    The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility.

    3 months

  • Number of sessions attended

    The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.

    3 months

  • Recruitment

    The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success.

    3 months

Secondary Outcomes (1)

  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores

    Baseline, 3 months, 6 months, and 9 months.

Other Outcomes (5)

  • Change in 30-second chair stand test

    Baseline, 3 months, 9 months

  • Change in 2-minute Step Test

    baseline, 3 months, 9 months

  • Change in Arm Curls

    Baseline, 3 months, 9 months

  • +2 more other outcomes

Study Arms (2)

Exercise Initiation and Maintenance with Text Messaging and Booster Sessions

EXPERIMENTAL

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.

Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions

Exercise Initiation and Maintenance with Text Messaging alone

ACTIVE COMPARATOR

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.

Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions

Interventions

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.

Exercise Initiation and Maintenance with Text Messaging aloneExercise Initiation and Maintenance with Text Messaging and Booster Sessions

Eligibility Criteria

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

You may qualify if:

  • diagnosis of symptomatic knee or hip OA
  • Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
  • physically inactive (add definition)

You may not qualify if:

  • No telephone access
  • hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months
  • recent hospitalization for cardiovascular/cerebrovascular event
  • serious mental health condition or behavioral issues precluding participating in group exercise
  • terminal illness
  • motor neuron diseases
  • severely impaired hearing, vision, or speech
  • non-English speaking
  • current participation in another OA or exercise intervention or lifestyle change study
  • other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study
  • no primary care physician visit in past 12 months
  • pregnant women
  • insufficient internet connectivity to participate in group telehealth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

MeSH Terms

Conditions

ArthritisOsteoarthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lauren Abbate, MD

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Abbate, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 27, 2022

Study Start

April 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations