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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline of psychological flexibility at immediately after the 4-week treatments
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blinded (participants and statistician)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have non-specific LBP in or near the lumbosacral spine with or without leg pain that lasts for at least 3-months in the last 12 months
- •have sought some medical or healthcare professional treatments for CLBP
- •able to read and write at an adequate level of proficiency in Chinese
- •Montreal Cognitive Assessment (MoCA) scores 22 or above
排除标准
- •people with malignant pain or lumbar spinal stenosis
- •confirmed dementia
- •severe cognitive impairment
- •serious psychiatric or psychological disorders
- •Montreal Cognitive Assessment (MoCA) scores below 22
研究组 & 干预措施
Older people with online ACT intervention
4 week ACT plus back exercise group
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Older people with online ACT intervention
4 week ACT plus back exercise group
干预措施: back exercise (Behavioral)
Older people without ACT intervention
4-week back exercise control group
干预措施: back exercise (Behavioral)
Older people without ACT intervention
4-week back exercise control group
干预措施: back care education (Behavioral)
结局指标
主要结局
Change from baseline of psychological flexibility at immediately after the 4-week treatments
时间窗: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description)
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. AAQII has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
次要结局
- Overall perceived changes in symptom severity, treatment response and the efficacy of treatment(Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment)
- Change of health-related quality of life(Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment)
- Change of LBP intensity(Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment)
- Change of LBP-related disability(Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment)
- Change of depression, anxiety, and stress(Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment)
研究者
Dr Arnold Wong Yu Lok
Associate Professor
The Hong Kong Polytechnic University