Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576414
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
Feasibility Effectiveness and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None