No study has investigated the effects of ACT on community-dwelling Chinese 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 ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical wellbeing, and quality of life of community-dwelling older people with CLBP. Further, a qualitative research study will be conducted to understand the experiences of participating in ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
Participants will be recruited from rehabilitation clinics, or community centres by posters posted in these locations. A total of 30 older people with LBP will be recruited and randomized into either a 4-week ACT plus back exercise group, or a back exercise control group. Immediately after the 4-week 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 wellbeing, and quality of life. At 3-month post-treatment, participants will be invited to complete the identical questionnaires again.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
30
Each session in the ACT group will include the first hour of ACT intervention followed by 1 hour of back exercise class. The ACT group will be led by a trained ACT counsellor and a trained exercise trainer.
The control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer.
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
RECRUITINGChange from baseline of psychological flexibility at immediately after the 4-week treatments
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means "never true" and 7 means "always true." The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Time frame: Baseline and at immediately after the 4-week treatments
Change of LBP intensity
An 11-point numeric pain rating scale will be used to measure LBP intensity, where 0 means no pain and 10 means the worst imaginable pain. Participants need to report their back pain in the current moment, in the last 24 hours and the last 3 months.
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of LBP-related disability
The Chinese version of 24-item Roland Morris Disability Index will be used to evaluate the LBP-related disability in older adults.30 It consists of 24 yes/no items related to LBP-related functional limitations. The summation of the scores of items with "yes" answer indicates the severity of LBP-related disability. The maximum score is 24.
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of health-related quality of life
The Chinese version of EQ-5D-5L will be used to measure health-related quality of life (HRQOL) in our participants. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 options (no problem, slight problems, moderate problems, severe problems, extreme problems/unable to). It has been found to useful in monitoring HRQOL responses to treatment.
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of depression, anxiety, and stress
The Chinese version of 21-item Depression, Anxiety Stress Scales (DASS) will be used to evaluate depression (7 items), anxiety (7 items), and stress (7 items) in older adults. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). Higher scores imply more mental health issues. It has been cross-culturally adapted to Hong Kong settings. DASS has demonstrated excellent internal consistency for depression, anxiety, and stress subscales.
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
Global impression of change scale will be used to evaluate the overall perceived changes in symptom severity, treatment response and the efficacy of treatment immediately after the 4 week interventions.
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change from baseline of psychological flexibility at 3-month post-treatment
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means "never true" and 7 means "always true." The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Time frame: Baseline and at 3-month post-treatment
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