Clinical trial NCT05535400: Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Physical Inactivity
Depression
Chronic Pain
Keywords: Spinal cord injuries
Physical Psychological Integrative
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We aim to have two study group, including the eight-week Physical-Psychological Integrative online intervention group and the brief online didactic education control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Leisure-time Physical Activity
timeFrame: Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.
measure: Depression at post-test
timeFrame: Depression will be assessed at post-intervention, an average of two months.
measure: Depression at three months follow-up
timeFrame: Depression will be assessed after three months follow-up.
measure: Chronic pain at post test
timeFrame: Chronic pain will be assessed at post-intervention, an average of two months.
measure: Chronic pain at three months follow-up
timeFrame: Chronic pain will be assessed after three months follow-up.
Secondary outcomes:
measure: Exercise Efficacy at post test
timeFrame: Exercise efficacy will be assessed at post-intervention, an average of two months.
measure: Exercise Efficacy at three months follow-up
timeFrame: Exercise Efficacy will be assessed after three months follow-up.
measure: Mindfulness at post test
timeFrame: Mindfulness will be assessed at post-intervention, an average of two months.
measure: Mindfulness at three months follow-up
timeFrame: Mindfulness will be assessed after three months follow-up.
measure: QoL: Quality of Life at post test
timeFrame: Quality of Life will be assessed at post-intervention, an average of two months.
measure: QoL: Quality of Life at three months follow up
timeFrame: Quality of Life will be assessed after three months follow-up.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic Unviersity
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yan Li, Dr
role: PRINCIPAL_INVESTIGATOR
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