Trials / Recruiting
RecruitingNCT06576414
Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain
Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises Versus Online Education Plus Exercises for Older People With Chronic Low Back Pain: A Pilot Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- The Hong Kong Polytechnic University · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
No study has investigated the effects of online ACT on community-dwelling older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with CLBP. A double-blinded (participants and statistician) pilot randomized controlled trial (RCT) will be conducted to evaluate the feasibility and the relative effects of online ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with CLBP at different time points. The clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. Further, a qualitative research study will be conducted to understand the experiences of participating in online ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
Detailed description
Recruitment posters will be displayed in five Hong Kong community centers. A total of 40 older people with LBP will be recruited and randomized to either a 4-week online ACT-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. All participants will be screened for eligibility. After providing the informed consent, participants will undergo baseline assessments. Then they will be randomized into either group. Immediately after the 4-week treatment and at 3- and 6-month post-treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological well-being, and quality of life. Semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. The interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Acceptance and Commitment Therapy (ACT) | the first hour of ACT intervention followed by 1 hour of back exercise class, which led by a trained ACT counsellor and a trained exercise trainer |
| BEHAVIORAL | back exercise | 1 hour of back exercise class led by a trained exercise trainer |
| BEHAVIORAL | back care education | 1 hour long interactive lesson to participants about LBP-related pathology, disability, psychology, and pain management skills. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2024-08-28
- Last updated
- 2024-08-28
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT06576414. Inclusion in this directory is not an endorsement.