Living Longer and Stronger With Spinal Cord Injury (SCI)

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
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Living Longer and Stronger With Spinal Cord Injury: An Online Program for Promoting Healthy Aging

Conditions

Spinal Cord Injuries

Being tested

Living Longer and Stronger with SCI, Control

Keywords

spinal cord injury, aging, health promotion, intervention, randomized controlled trial

Medical subject headings

Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Living Longer and Stronger with SCIBehavioural

  Study staff will schedule a brief zoom training session with each person assigned to the intervention to ensure that they are able to download and use the Zoom platform. Once a weekly session day and time has been determined the 8-week LLS intervention program will begin. LLS group participants will participate in 2-hour weekly sessions co-facilitated by a study investigator and one of the study's senior advisors. Participants will be encouraged to set a health-oriented goal and complete weekly action plans. They will be provided with materials each week with health-related information and resources. Participants will also be asked to complete a short survey each week to rate the session. After completing the 8 sessions, a link to the post-test survey and some questions to evaluate the LLS program will be sent to the participants. Finally there will be follow up survey to be completed at 4 months post intervention.

• ControlBehavioural

  Participants will be sent links to the three surveys at the same time as those assigned to the LLS group but they will not attend any of the zoom calls. They will be offered all study materials at the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change in physical health as assessed by the SF-36 General Health Subscale

   a 5-item scale of self-perceived health. The subscale consists of a single-item rating of health and four additional items reflecting perceived current health, resistance to illness and health outlook. Individual item responses range from 1-5. To score, select items (1, 3, and 5) are recoded so that higher scores indicate better health. The 5 items are then summed and transformed to a 0-100 scale with higher scores reflecting better health.

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

2. Change in physical health as assessed by the Pain Intensity scale

   This consists of one item assessing pain intensity/severity rated on a 11-point scale ranging from 0 (no pain) to 10 (pain so severe you couldn't stand it), higher score indicting worse pain

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

3. Change in physical health as assessed by the Interference scale

   This is a 1 item questionnaire that is scored on a linear scale from 0 (no interference)-10 (extreme interference), higher score indicting worse outcome

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

4. Change in physical health as assessed by the SCI Secondary Conditions Scale (SCI-SCS)

   This is a 16 item questionnaire and each item scores range from 0 (not experienced or insignificant problem) to 3 (significant or chronic problem). Items are summed with a potential score range of 0-48 with higher scores reflecting more severe secondary health conditions.

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

5. Change in psychological health and wellbeing as assessed by the Patient Health Questionaire-8 (PHQ-8)

   This is an 8 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 24 higher score indicating worse outcome

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

6. Change in psychological health and wellbeing as assessed by the Generalized Anxiety Disorder (GAD-2) scale

   This is a 2 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 6 higher score indicating worse outcome

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

7. Change in psychological health and wellbeing as assessed by the 4-itemPerceived Stress Scale (PSS)

   This is a 4 item questionnaire and questions 1 and 4 are scored from 0(never) to 4(very often) , and questions 2 and 3 are scored from 0(very often) to 4 (never) for a maximum score of 16 higher score indicating worse outcome

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

8. Change in psychological health and wellbeing as assessed by the SCI-Qol Positive Affect and Well-being Scale

   This is a 10 item questionnaire, and each is scored from from 1 (never) to 5 (always). Items are summed to create a raw score. Raw scores are then converted to an IRT-based T-score using provided look-up tables. T-scores range from 26.7 to 68.6 with higher scores representing more positive affect and well-being.

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

9. Change in psychological health and wellbeing as assessed by the Diener Satisfaction with Life Scale (SWLS)

   This is a 4 item questionnaire and each is scored on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores are summed resulting in a scale score ranging from 4 to 28 with higher scores representing greater life satisfaction.

   Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

10. Change in social health as assessed by the UCLA Loneliness scale

    This is a 3 item questionnaire and each is scored from 1(hardly ever) to 3(often) for a maximum score of 9 higher score indicating worse outcome

    Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

11. Change in social health as assessed by the Spinal Cord Injury - Quality of Life Scale (SCI-QOL) Satisfaction with Participation Scale

    This is a 10 item questionnaire and each is scored from 1(not at all) to 5(very much ) with the scale direction depending on whether the item is positively or negatively worded. Item scores are summed to create a raw score which is then converted to an IRT-based T-score using look-up tables. T-scores range from 28.3 to 60.5 with higher scores representing more satisfaction with social roles and activities.

    Measured: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Jan 2024
2. Study start13 Feb 2024
3. Primary completion1 Jul 2026 (estimated)
4. Study completion1 Jul 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
• More trials run by The University of Texas Health Science Center, HoustonThe 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.