Telehealth Exercise Program for Arthritis

Overseen By Andrew T Stephens

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Recent surgery, Cardiovascular event, Mental health, Terminal illness, Motor neuron diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your primary care physician.

What data supports the effectiveness of the Telehealth Exercise Program for Arthritis treatment?

Research shows that telehealth exercise programs, like those used for knee osteoarthritis and older adults, can improve physical function and are as effective as in-person sessions. Participants also reported benefits such as improved balance and high attendance rates, indicating that virtual exercise therapy can be a viable option for managing arthritis. ^{1 2 3 4 5}

Is the Telehealth Exercise Program safe for humans?

Research on telehealth exercise programs, including those for older adults, shows they are generally safe and can improve physical function without significant differences compared to in-person sessions. Participants in these programs have reported positive experiences and benefits such as improved balance. ^{2 5 6 7 8}

How is the Telehealth Exercise Program for Arthritis different from other treatments?

The Telehealth Exercise Program for Arthritis is unique because it allows patients to participate in group exercise sessions from home using live video, which can improve physical function and maintain high attendance rates, similar to in-person sessions, but with the added convenience of remote access. ^{1 2 5 9 10}

Research Team

Lauren Abbate, MD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

This trial is for Veterans with knee or hip arthritis who are patients at Eastern Colorado Healthcare System, haven't been active lately, and have had a VA visit in the past year. It's not for those without phone access, recent serious health events, current participation in similar studies, or conditions that would limit joining group exercises.

Inclusion Criteria

Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year

I have been diagnosed with painful knee or hip arthritis.

Physically inactive individuals (defined as...)

Exclusion Criteria

I haven't seen a primary care doctor in the last year.

I have had hip or knee surgery, or a recent severe knee injury.

I was recently hospitalized for a heart or stroke-related event.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Initiation

Participants receive a group telehealth exercise program for 3 months

3 months

Weekly group telehealth sessions

Exercise Maintenance

Participants continue with text messaging alone or text messaging plus monthly group telehealth exercise booster sessions

6 months

Monthly group telehealth sessions for booster group

Follow-up

Participants are monitored for changes in physical activity and osteoarthritis symptoms

3 months

Data collection at 3-, 6-, and 9-month follow-up

Treatment Details

Interventions

• Group Telehealth Exercise Sessions

Trial Overview The study tests a telehealth exercise program for Veterans with arthritis over 9 months. Participants will do group exercises via telehealth for 3 months followed by text message support or additional booster sessions to maintain exercise habits.

Participant Groups

Group I: Exercise Initiation and Maintenance with Text Messaging and Booster Sessions Experimental Treatment 1 Intervention

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.

Group II: Exercise Initiation and Maintenance with Text Messaging alone Active Control 1 Intervention

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

Group Telehealth Exercise Sessions is already approved in United States for the following indications:

Approved in United States as Group Telehealth Exercise Sessions for:

• Lower extremity osteoarthritis (OA)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Patients who participated in telehealth for knee osteoarthritis found it to be easy, convenient, and flexible, leading to a positive perception of its acceptability, especially among those with prior exposure to telehealth.

Both telehealth and in-person participants reported similar benefits from the GLA:D® program, including reduced fear of pain, improved beliefs about exercise, and enhancements in pain and function, suggesting that telehealth can effectively provide high-quality care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Much better than I thought it was going to be": Telehealth delivered group-based education and exercise was perceived as acceptable among people with knee osteoarthritis. Ezzat, AM., Bell, E., Kemp, JL., et al.[2022]

Live video exercise groups for older adults showed improvements in physical function, with no significant differences compared to in-person sessions, based on a systematic review of nine studies involving participants aged 65 and older.

Participants in a case study reported similar attendance rates and benefits, such as improved balance, from both virtual and in-person sessions, suggesting that live video formats can be an effective alternative for exercise programs during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Function Effects of Live Video Group Exercise Interventions for Older Adults: A Systematic Review and Veteran's Gerofit Group Case Study. Fernandez, D., Wilkins, SS., Melrose, RJ., et al.[2023]

Participants with knee osteoarthritis who attended more physical therapy (PT) visits showed significant improvements in overall knee function and pain, with benefits lasting up to 8 months after treatment, based on a study of 259 individuals.

In contrast, the use of an internet-based exercise training (IBET) program did not lead to significant improvements in any measured outcomes, suggesting that traditional PT may be more effective for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Level of participation in physical therapy or an internet-based exercise training program: associations with outcomes for patients with knee osteoarthritis. Pignato, M., Arbeeva, L., Schwartz, TA., et al.[2019]

In a study of 345 participants with knee osteoarthritis, telehealth-delivered exercise programs significantly improved pain and function, with increased arthritis self-efficacy and reduced fear of movement identified as key mediators of these improvements.

The combination of diet and exercise led to additional benefits, including weight loss, which further enhanced pain reduction and functional improvements compared to exercise alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects. Lawford, BJ., Hinman, RS., McManus, F., et al.[2023]

The Gerofit facility-based exercise program successfully transitioned to a telehealth format during COVID-19, allowing 27% of participating Veterans to continue exercising remotely.

Remote physical performance testing indicated that participants were able to retain their physical function, suggesting that telehealth exercise programs can effectively mitigate health risks associated with decreased mobility in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. Jennings, SC., Manning, KM., Bettger, JP., et al.[2021]

The telehealth-delivered Otago exercise program successfully engaged 21 low-income older adults over 12 weeks, promoting physical activity and potentially reducing fall risks, as it is a CDC-endorsed program for improving balance and strength.

Postintervention interviews highlighted significant differences in community engagement and mental health concerns, with one site experiencing high participation and social interaction, while the other faced issues of depression and isolation, indicating the need for integrated mental health support in similar programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When More Than Exercise Is Needed to Increase Chances of Aging in Place: Qualitative Analysis of a Telehealth Physical Activity Program to Improve Mobility in Low-Income Older Adults. VanRavenstein, K., Davis, BH.[2020]

In a study involving 197 participants with arthritis, a self-directed exercise program showed high engagement, with 73.2% reading most materials and 90.4% rating the program as 'good' or 'excellent' after 12 weeks.

The program effectively encouraged self-management behaviors, as 63.3% set goals and 83.9% reported success in following their plans, although there was a decline in the use of self-monitoring logs over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Participation, satisfaction, perceived benefits, and maintenance of behavioral self-management strategies in a self-directed exercise program for adults with arthritis". Sharpe, PA., Wilcox, S., Schoffman, DE., et al.[2019]

The revised 6-week Walk With Ease (WWE) program significantly improved self-reported outcomes and performance measures in adults with arthritis, showing benefits in disability, pain, fatigue, and strength, with no reported adverse events.

Both instructor-led and self-directed formats of the WWE program were effective, with self-directed participants maintaining more significant improvements in certain outcomes at the 1-year mark, highlighting the program's safety and accessibility for promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. Callahan, LF., Shreffler, JH., Altpeter, M., et al.[2011]

A study involving 10 adults with cystic fibrosis demonstrated that assessing exercise capacity through a 3-minute step test via telehealth is feasible and accurate, with no significant differences in physiological responses compared to in-person assessments.

Participants reported high usability of the telehealth system, achieving an average score of 85.63 out of 100, although they noted that the sound quality of the metronome was significantly poorer during remote assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing exercise capacity using telehealth: a feasibility study in adults with cystic fibrosis. Cox, NS., Alison, JA., Button, BM., et al.[2013]

Clinical video telehealth is an effective method for providing functional circuit exercise training to older veterans who live in remote areas, ensuring they have access to important physical activity.

This approach allows for personalized exercise programs to be delivered safely and effectively, improving the health and well-being of older veterans without the need for them to travel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Rural Veterans With Access to Exercise Through Gerofit. Briggs, BC., Jain, C., Morey, MC., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

"Much better than I thought it was going to be": Telehealth delivered group-based education and exercise was perceived as acceptable among people with knee osteoarthritis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Physical Function Effects of Live Video Group Exercise Interventions for Older Adults: A Systematic Review and Veteran's Gerofit Group Case Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Level of participation in physical therapy or an internet-based exercise training program: associations with outcomes for patients with knee osteoarthritis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

When More Than Exercise Is Needed to Increase Chances of Aging in Place: Qualitative Analysis of a Telehealth Physical Activity Program to Improve Mobility in Low-Income Older Adults. [2020]

7. England pubmed.ncbi.nlm.nih.gov

"Participation, satisfaction, perceived benefits, and maintenance of behavioral self-management strategies in a self-directed exercise program for adults with arthritis". [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Assessing exercise capacity using telehealth: a feasibility study in adults with cystic fibrosis. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Providing Rural Veterans With Access to Exercise Through Gerofit. [2020]