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

April 8, 2024 updated by: The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, The Hong Kong Polytechnic Unviersity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Physical-Psychological Integrative (PPI) intervention group
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
Behavioral: Physical-Psychological Integrative Intervention
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. And the content of the intervention includes eight different sessions, including Session 1- Orientation and engagement, Session 2- Awareness and Acceptance; Session 3- Non-judgement; Session 4- Stay present and let go; Session 5- Our thoughts are not real & Response without reacting; Session 6- Empowerment of self-management and discuss pain management; Session 7- Seek out pleasant things and social support and Session 8- Review the intervention and end the programme.
Active Comparator: The brief online didactic education control group
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.
Device: Brief online didactic education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leisure-time Physical Activity
Time Frame: 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.
Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.
Depression at post-test
Time Frame: 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.
Depression will be assessed at post-intervention, an average of two months.
Depression at three months follow-up
Time Frame: 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.
Depression will be assessed after three months follow-up.
Chronic pain at post test
Time Frame: 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 will be assessed at post-intervention, an average of two months.
Chronic pain at three months follow-up
Time Frame: 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.
Chronic pain will be assessed after three months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Efficacy at post test
Time Frame: Exercise efficacy will be assessed at post-intervention, an average of two months.
A scale aim at testing people's confidence to continue exercising in the face of barriers to exercise.
Exercise efficacy will be assessed at post-intervention, an average of two months.
Exercise Efficacy at three months follow-up
Time Frame: Exercise Efficacy will be assessed after three months follow-up.
A scale aim at testing people's confidence to continue exercising in the face of barriers to exercise.
Exercise Efficacy will be assessed after three months follow-up.
Mindfulness at post test
Time Frame: Mindfulness will be assessed at post-intervention, an average of two months.
The 39-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measuring the five aspects of mindfulness including observing, describing, acting with awareness, non-judgmental and non-reactive.
Mindfulness will be assessed at post-intervention, an average of two months.
Mindfulness at three months follow-up
Time Frame: Mindfulness will be assessed after three months follow-up.
The 39-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measuring the five aspects of mindfulness including observing, describing, acting with awareness, non-judgmental and non-reactive.
Mindfulness will be assessed after three months follow-up.
QoL: Quality of Life at post test
Time Frame: Quality of Life will be assessed at post-intervention, an average of two months.
The 26-item World Health Organization Quality of Life Brief Scale will be used for assessing participants' quality of life.
Quality of Life will be assessed at post-intervention, an average of two months.
QoL: Quality of Life at three months follow up
Time Frame: Quality of Life will be assessed after three months follow-up.
The 26-item World Health Organization Quality of Life Brief Scale will be used for assessing participants' quality of life.
Quality of Life will be assessed after three months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Yan Li, Dr, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0038951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Physical-Psychological Integrative Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe