Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial

The Hong Kong Polytechnic University

Status: Completed

Conditions: Physical Inactivity; Spinal Cord Injuries; Chronic Pain; Depression

Treatments: Device: Brief online didactic education; Behavioral: Physical-Psychological Integrative Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05535400

P0038951

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

The Physical-Psychological Integrative (PPI) intervention group

Experimental group

Description:

The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program, followed by on-line group psychological intervention

Treatment:

Behavioral: Physical-Psychological Integrative Intervention

The brief online didactic education control group

Active Comparator group

Description:

Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.

Treatment:

Device: Brief online didactic education