Health Program for Spinal Cord Injury

(LLS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Susan Robinson-Whelen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Cognitive impairment, Visual impairment, Suicidality, Drug use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a health promotion group intervention to meet the unique health promotion needs of people aging with SCI, to test the efficacy of the adapted intervention program, Living Longer and Stronger with SCI, in a randomized controlled trial and to assess the mechanisms through which the intervention may enhance physical, psychological, and social health.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Living Longer and Stronger with SCI, LLS Program for spinal cord injury?

The research highlights that specialized medical care and active lifestyle interventions can improve life expectancy and quality of life for people with spinal cord injury by preventing inactive lifestyles and associated health issues. This suggests that programs like Living Longer and Stronger with SCI, which likely incorporate these elements, could be effective in supporting healthy aging and improving overall well-being in individuals with spinal cord injury. ^{1 2 3 4 5}

How is the Living Longer and Stronger with SCI treatment different from other treatments for spinal cord injury?

The Living Longer and Stronger with SCI treatment is unique because it focuses on promoting an active lifestyle and self-management to improve health and quality of life for people with spinal cord injuries, rather than just addressing medical symptoms. This approach aims to prevent secondary health conditions and enhance overall well-being through behavioral changes. ^{1 3 6 7 8}

Research Team

Susan Robinson-Whelen, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals who are aging with a spinal cord injury (SCI). Specific criteria to join the study aren't provided, but typically participants would need to meet certain health conditions related to their SCI.

Inclusion Criteria

Reside in the U.S.

I have a spinal cord injury due to trauma.

I use a wheelchair for moving around, at least occasionally.

Exclusion Criteria

Live in an institution

Have a significant visual or hearing impairment that would prohibit their ability to participate in the interactive online intervention with accommodations

Report active suicidality or significant problems with alcohol or other drug use

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Living Longer and Stronger with SCI program to promote healthy aging

8 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for changes in physical, psychological, and social health

4 months

Monthly check-ins (virtual)

Treatment Details

Interventions

• Living Longer and Stronger with SCI (Behavioral Intervention)

Trial Overview The study is testing a new group intervention program called 'Living Longer and Stronger with SCI' designed to improve physical, psychological, and social health in people with SCI. It's compared against a control group in a randomized controlled trial.

Participant Groups

Group I: Living Longer and Stronger (LLS) intervention Experimental Treatment 1 Intervention

Group II: Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Dr. Kristi Hill

National Institute on Disability, Independent Living, and Rehabilitation Research

Acting Director since 2012

PhD in Neuroscience from the Medical College of Virginia

Dr. Phillip Beatty

National Institute on Disability, Independent Living, and Rehabilitation Research

Director of the Office of Research Sciences since 2019

PhD in Rehabilitation Sciences

Findings from Research

The Swedish Aging with Spinal Cord Injury Study involved 123 participants aged 50 and older with at least 10 years of spinal cord injury, aiming to understand factors that contribute to healthy aging in this population.

Initial results showed that most participants were married or partnered, with a significant portion still working, indicating that many individuals with long-term SCI maintain active and engaged lifestyles despite their injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Swedish Aging With Spinal Cord Injury Study (SASCIS): Methodology and Initial Results. Jörgensen, S., Iwarsson, S., Norin, L., et al.[2018]

The HABITS study, involving 64 individuals with long-term spinal cord injury, found that a 16-week structured self-management intervention did not significantly improve physical activity levels or related behavioral outcomes compared to a control group.

Despite the intervention's design to promote an active lifestyle, the results indicated no effective change in participants' attitudes, self-efficacy, or stages of change regarding exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Self-Management Intervention to Promote an Active Lifestyle in Persons With Long-Term Spinal Cord Injury: The HABITS Randomized Clinical Trial. Kooijmans, H., Post, MWM., Stam, HJ., et al.[2022]

In-hospital mortality rates for spinal cord injury (SCI) patients vary significantly by WHO region, with the highest rate at 24.1% in Africa and the lowest at 2.1% in the Western Pacific, indicating a strong influence of regional healthcare systems.

Survival rates in the first year post-SCI are notably higher in high-income regions, with 95.6% in Europe and 94.0% in the Western Pacific, compared to lower rates in low- and middle-income countries, highlighting disparities in healthcare access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and longevity after a spinal cord injury: systematic review and meta-analysis. Chamberlain, JD., Meier, S., Mader, L., et al.[2022]

A study involving 26 participants (13 women and 13 men) identified 67 factors influencing physical activity participation among individuals with spinal cord injury (SCI), highlighting the importance of both environmental and personal factors.

Gender differences were noted in areas such as social support and athletic identity, suggesting that tailored approaches may be needed to encourage physical activity, especially among women with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in physical activity in persons with spinal cord injury: a comprehensive perspective and insights into gender differences. Rauch, A., Fekete, C., Cieza, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Cross-Cultural Societal Response to SCI: Health and Related Systems. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

The Swedish Aging With Spinal Cord Injury Study (SASCIS): Methodology and Initial Results. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Active LifestyLe Rehabilitation interventions in aging spinal cord injury (ALLRISC): a multicentre research program. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Current research outcomes from the spinal cord injury model systems. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Health status rated with the Medical Outcomes Study 36-Item Short-Form Health Survey after spinal cord injury. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Self-Management Intervention to Promote an Active Lifestyle in Persons With Long-Term Spinal Cord Injury: The HABITS Randomized Clinical Trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mortality and longevity after a spinal cord injury: systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Participation in physical activity in persons with spinal cord injury: a comprehensive perspective and insights into gender differences. [2022]