Spinal Cord InjuriesNCT05535400
Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial
A study testing Physical-Psychological Integrative Intervention and Brief online didactic education in people with Spinal Cord Injuries and Physical Inactivity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Physical Inactivity, Depression
- What is being tested?
- Physical-Psychological Integrative Intervention and Brief online didactic education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Sep 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic Unviersity
Hong Kong
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Physical Inactivity, Depression, Chronic Pain
- Being tested
- Physical-Psychological Integrative Intervention, Brief online didactic education
- Keywords
- Spinal cord injuries, Physical Psychological Integrative
- Medical subject headings
- Spinal Cord Injuries, Sedentary Behavior, Depression, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical-Psychological Integrative InterventionBehavioural
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.
Brief online didactic educationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The Physical-Psychological Integrative (PPI) intervention group | Experimental | 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 Receives: Behavioral: Physical-Psychological Integrative Intervention |
| The brief online didactic education control group | Active comparator | 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. Receives: Device: Brief online didactic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leisure-time Physical Activity
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.
Measured: Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.
Depression at post-test
The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.
Measured: Depression will be assessed at post-intervention, an average of two months.
Depression at three months follow-up
The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.
Measured: Depression will be assessed after three months follow-up.
Chronic pain at post test
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.
Measured: Chronic pain will be assessed at post-intervention, an average of two months.
Chronic pain at 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.
Measured: Chronic pain will be assessed after three months follow-up.
Secondary outcomes (6)
Exercise Efficacy at post test
A scale aim at testing people's confidence to continue exercising in the face of barriers to exercise.
Measured: Exercise efficacy will be assessed at post-intervention, an average of two months.
Exercise Efficacy at three months follow-up
A scale aim at testing people's confidence to continue exercising in the face of barriers to exercise.
Measured: Exercise Efficacy will be assessed after three months follow-up.
Mindfulness at post test
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.
Measured: Mindfulness will be assessed at post-intervention, an average of two months.
Mindfulness at 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.
Measured: Mindfulness will be assessed after three months follow-up.
QoL: Quality of Life at post test
The 26-item World Health Organization Quality of Life Brief Scale will be used for assessing participants' quality of life.
Measured: Quality of Life will be assessed at post-intervention, an average of two months.
QoL: Quality of Life at three months follow up
The 26-item World Health Organization Quality of Life Brief Scale will be used for assessing participants' quality of life.
Measured: Quality of Life will be assessed after three months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start20 Sep 2022
- Primary completion31 Dec 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Li, Dr, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535400
- Sponsor's protocol ID
- P0038951
- Status last verified
- Jun 2022
- First submitted
- 11 Jul 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alizadeh A, Dyck SM, Karimi-Abdolrezaee S. Traumatic Spinal Cord Injury: An Overview of Pathophysiology, Models and Acute Injury Mechanisms. Front Neurol. 2019 Mar 22;10:282. doi: 10.3389/fneur.2019.00282. eCollection 2019.
PubMed 30967837March ICfCoSCIPJI. Global summary of spinal cord injury, incidence and economic impact. 2004.
Margolis JM, Juneau P, Sadosky A, Cappelleri JC, Bryce TN, Nieshoff EC. Health care resource utilization and medical costs of spinal cord injury with neuropathic pain in a commercially insured population in the United States. Arch Phys Med Rehabil. 2014 Dec;95(12):2279-87. doi: 10.1016/j.apmr.2014.07.416. Epub 2014 Aug 24.
PubMed 25159715Hu Y, Mak JN, Wong YW, Leong JC, Luk KD. Quality of life of traumatic spinal cord injured patients in Hong Kong. J Rehabil Med. 2008 Feb;40(2):126-31. doi: 10.2340/16501977-0150.
PubMed 18509577Martin Ginis KA, Jetha A, Mack DE, Hetz S. Physical activity and subjective well-being among people with spinal cord injury: a meta-analysis. Spinal Cord. 2010 Jan;48(1):65-72. doi: 10.1038/sc.2009.87. Epub 2009 Jul 7.
PubMed 19581918Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20.
PubMed 27809702Khazaeipour Z, Taheri-Otaghsara SM, Naghdi M. Depression Following Spinal Cord Injury: Its Relationship to Demographic and Socioeconomic Indicators. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):149-55. doi: 10.1310/sci2102-149. Epub 2015 Apr 12.
PubMed 26364284Bombardier CH, Richards JS, Krause JS, Tulsky D, Tate DG. Symptoms of major depression in people with spinal cord injury: implications for screening. Arch Phys Med Rehabil. 2004 Nov;85(11):1749-56. doi: 10.1016/j.apmr.2004.07.348.
PubMed 15520969Hadjipavlou G, Cortese AM, Ramaswamy B. Spinal cord injury and chronic pain. BJA Education. 2016;16(8):264-8.
Avluk OC, Gurcay E, Gurcay AG, Karaahmet OZ, Tamkan U, Cakci A. Effects of chronic pain on function, depression, and sleep among patients with traumatic spinal cord injury. Ann Saudi Med. 2014 May-Jun;34(3):211-6. doi: 10.5144/0256-4947.2014.211.
PubMed 25266180Best KL, Routhier F, Sweet SN, Lacroix E, Arbour-Nicitopoulos KP, Borisoff JF. Smartphone-Delivered Peer Physical Activity Counseling Program for Individuals With Spinal Cord Injury: Protocol for Development and Pilot Evaluation. JMIR Res Protoc. 2019 Mar 22;8(3):e10798. doi: 10.2196/10798.
PubMed 30901001Bombardier CH, Dyer JR, Burns P, Crane DA, Takahashi MM, Barber J, Nash MS. A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial. Spinal Cord. 2021 Jan;59(1):63-73. doi: 10.1038/s41393-020-0523-6. Epub 2020 Jul 21.
PubMed 32694748Boldt I, Eriks-Hoogland I, Brinkhof MW, de Bie R, Joggi D, von Elm E. Non-pharmacological interventions for chronic pain in people with spinal cord injury. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD009177. doi: 10.1002/14651858.CD009177.pub2.
PubMed 25432061Fann JR, Crane DA, Graves DE, Kalpakjian CZ, Tate DG, Bombardier CH. Depression treatment preferences after acute traumatic spinal cord injury. Arch Phys Med Rehabil. 2013 Dec;94(12):2389-2395. doi: 10.1016/j.apmr.2013.07.004. Epub 2013 Jul 16.
PubMed 23872078Heutink M, Post MW, Luthart P, Schuitemaker M, Slangen S, Sweers J, Vlemmix L, Lindeman E. Long-term outcomes of a multidisciplinary cognitive behavioural programme for coping with chronic neuropathic spinal cord injury pain. J Rehabil Med. 2014 Jun;46(6):540-5. doi: 10.2340/16501977-1798.
PubMed 24818861
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05535400
- Acronym / sponsor ID
- P0038951
- Conditions
- Spinal Cord Injuries, Physical Inactivity, Depression, Chronic Pain
- Keywords
- Spinal cord injuries, Physical Psychological Integrative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Physical-Psychological Integrative (PPI) intervention group | Experimental | Behavioral: Physical-Psychological Integrative InterventionThe 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 |
| The brief online didactic education control group | Active comparator | Device: Brief online didactic educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical-Psychological Integrative InterventionThe 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. | Behavioural | The Physical-Psychological Integrative (PPI) intervention group |
| Brief online didactic educationParticipants 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 | The brief online didactic education control group |
Primary outcome
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.
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 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.
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 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.
6 secondary outcomes
Exercise Efficacy at post test
Time frame: 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.
Mindfulness at post test
Time frame: 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.
QoL: Quality of Life at post test
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 30967837Alizadeh A, Dyck SM, Karimi-Abdolrezaee S. Traumatic Spinal Cord Injury: An Overview of Pathophysiology, Models and Acute Injury Mechanisms. Front Neurol. 2019 Mar 22;10:282. doi: 10.3389/fneur.2019.00282. eCollection 2019.
- BackgroundMarch ICfCoSCIPJI. Global summary of spinal cord injury, incidence and economic impact. 2004.
- Background: PubMed 25159715Margolis JM, Juneau P, Sadosky A, Cappelleri JC, Bryce TN, Nieshoff EC. Health care resource utilization and medical costs of spinal cord injury with neuropathic pain in a commercially insured population in the United States. Arch Phys Med Rehabil. 2014 Dec;95(12):2279-87. doi: 10.1016/j.apmr.2014.07.416. Epub 2014 Aug 24.
- Background: PubMed 18509577Hu Y, Mak JN, Wong YW, Leong JC, Luk KD. Quality of life of traumatic spinal cord injured patients in Hong Kong. J Rehabil Med. 2008 Feb;40(2):126-31. doi: 10.2340/16501977-0150.
- Background: PubMed 19581918Martin Ginis KA, Jetha A, Mack DE, Hetz S. Physical activity and subjective well-being among people with spinal cord injury: a meta-analysis. Spinal Cord. 2010 Jan;48(1):65-72. doi: 10.1038/sc.2009.87. Epub 2009 Jul 7.
- Background: PubMed 27809702Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20.
- Background: PubMed 26364284Khazaeipour Z, Taheri-Otaghsara SM, Naghdi M. Depression Following Spinal Cord Injury: Its Relationship to Demographic and Socioeconomic Indicators. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):149-55. doi: 10.1310/sci2102-149. Epub 2015 Apr 12.
- Background: PubMed 15520969Bombardier CH, Richards JS, Krause JS, Tulsky D, Tate DG. Symptoms of major depression in people with spinal cord injury: implications for screening. Arch Phys Med Rehabil. 2004 Nov;85(11):1749-56. doi: 10.1016/j.apmr.2004.07.348.
- BackgroundHadjipavlou G, Cortese AM, Ramaswamy B. Spinal cord injury and chronic pain. BJA Education. 2016;16(8):264-8.
- Background: PubMed 25266180Avluk OC, Gurcay E, Gurcay AG, Karaahmet OZ, Tamkan U, Cakci A. Effects of chronic pain on function, depression, and sleep among patients with traumatic spinal cord injury. Ann Saudi Med. 2014 May-Jun;34(3):211-6. doi: 10.5144/0256-4947.2014.211.
- Background: PubMed 30901001Best KL, Routhier F, Sweet SN, Lacroix E, Arbour-Nicitopoulos KP, Borisoff JF. Smartphone-Delivered Peer Physical Activity Counseling Program for Individuals With Spinal Cord Injury: Protocol for Development and Pilot Evaluation. JMIR Res Protoc. 2019 Mar 22;8(3):e10798. doi: 10.2196/10798.
- Background: PubMed 32694748Bombardier CH, Dyer JR, Burns P, Crane DA, Takahashi MM, Barber J, Nash MS. A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial. Spinal Cord. 2021 Jan;59(1):63-73. doi: 10.1038/s41393-020-0523-6. Epub 2020 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Li, Dr principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical-Psychological Integrative Intervention and Brief online didactic education in people with Spinal Cord Injuries and Physical Inactivity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leisure-time Physical Activity (time frame: Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535400, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.