Effects of a Physical-Psychological Integrative (PPI) Intervention on Physical Inactivity, Depression and Chronic Pain for Community-Dwelling Spinal Cord Injury Survivors: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Leisure-time Physical Activity
研究概览
简要总结
Spinal cord injury (SCI) is a neurological disorder that leads to "partial or complete loss of people's motor and/ or sensory function below the level of the injury".
The PPI intervention group participants will indicate significantly greater improvements when compared with those in control group in the minutes of performing the moderate-to-rigorous physical activity, depression, chronic pain and mindfulness skills and quality of life at post-intervention, and three months follow-up. The use of psychological motivational interviewing and online face-to-face meetings will be good modalities for the people with SCI to overcome the barriers of not having face-to-face interactions and transportation problems. And the intervention would be feasible and improve SCI people's physical inactivity, depression and chronic pain as to step up the control of the modifiable risk factors for non-communicable diseases.
详细描述
This study is a two-arm, single-blind pilot randomized controlled trial, and it will be adopted to evaluate or compare the effects between the Physical-Psychological Integrative (PPI) intervention group and the brief online didactic education control group.
Seventy-two participants will be recruited from the Hong Kong Direction Association for the Handicapped. 36 people with SCI will be assigned to intervention or control group. Participants in PPI Intervention group will receive a Fitbug wristband activity trackers and exercise bands as an incentive and encouragement for doing more physical exercises. The intervention includes eight weekly online group sessions. Qualitative interviews with the PPI intervention group participants will be conducted to understand their acceptance and perceived strengths and limitations of the intervention programme. While the one in the control group will receive a short video call for general physical and psychological suggestions. This can help to control the contact effects of the PPI intervention. Primary outcomes will be leisure-time physical activity, depression and chronic pain. Secondary outcome will be exercise efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The participants could not be blinded due to the nature of the intervention. Patients will be reminded to keep the intervention content confidential and not discuss this with participants in the control group to avoid contamination. Also, the research assistant (RA1) who responsible for assessing all the outcomes will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years older;
- •Currently living in the community and having SCI for more than 6 months;
- •Complete injury at the C6 or below or incomplete injury at any level ;
- •Having a computer/ smartphone with audio-speaking function and Zoom software, and internet access in a secure place;
- •Using a wheelchair for at least 2 hours a day and having the approval from the physicians to perform exercises;
- •Having no problems in hearing, verbal communication, and vision;
- •Able to communicate in Cantonese and to provide informed consent.
排除标准
- •Presented with any significant cognitive impairment or brain injury;
- •Engaged in ongoing psychotherapy or any other physiotherapy/ exercise/ relaxation interventions;
- •Physically active for more than 150 minutes per week;
- •Experiencing significant psychotic symptoms, substance misuse or medically not able for the exercise and psychological programme as diagnosed by their physicians.
结局指标
主要结局
Leisure-time Physical Activity
时间窗: Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.
Participants' leisure-time moderated-to-rigorous physical activity (MVPA) will be assessed by using the Fitbug Orb (Chicago, IL) which is a wearable, display, triaxial accelerometer that pairs with Bluetooth with compatible smartphones.
Depression at post-test
时间窗: Depression will be assessed at post-intervention, an average of two months.
The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.
Chronic pain at post test
时间窗: Chronic pain will be assessed at post-intervention, an average of two months.
An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain.
Chronic pain at three months follow-up
时间窗: Chronic pain will be assessed after three months follow-up.
An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain.
Depression at three months follow-up
时间窗: Depression will be assessed after three months follow-up.
The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.
次要结局
- Exercise Efficacy at post test(Exercise efficacy will be assessed at post-intervention, an average of two months.)
- Mindfulness at post test(Mindfulness will be assessed at post-intervention, an average of two months.)
- QoL: Quality of Life at post test(Quality of Life will be assessed at post-intervention, an average of two months.)
- Exercise Efficacy at three months follow-up(Exercise Efficacy will be assessed after three months follow-up.)
- QoL: Quality of Life at three months follow up(Quality of Life will be assessed after three months follow-up.)
- Mindfulness at three months follow-up(Mindfulness will be assessed after three months follow-up.)