Health Program for Spinal Cord Injury

(LLS Trial)

Recruiting at 1 trial location

Overseen By Diana Gonzalez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with spinal cord injuries (SCI) live healthier lives as they age. It tests a program called "Living Longer and Stronger with SCI" to evaluate its impact on physical, mental, and social health. The trial includes two groups: one follows the new program, and the other does not, allowing for a comparison of results. It is suitable for individuals in the U.S. who have had a spinal cord injury for at least 15 years or are over 45, use a wheelchair, and have internet access. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance the quality of life for SCI patients.

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 prior data suggests that the Living Longer and Stronger with SCI program is safe for people with spinal cord injury?

Research shows that the "Living Longer and Stronger with SCI" program helps people with spinal cord injuries maintain health as they age. This program promotes staying active and teaches skills for managing personal health.

Specific safety data for this program is not available, but it is generally considered safe because it emphasizes lifestyle changes rather than medication or surgery, which usually means fewer risks or side effects.

For those considering joining this trial, similar health programs are often well-received. However, discussing any concerns with the trial coordinators or a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The "Living Longer and Stronger (LLS) intervention" is unique because it focuses on lifestyle and rehabilitation methods specifically tailored for individuals with spinal cord injuries (SCI). Unlike standard treatments that often emphasize medical management and physical therapy, LLS aims to enhance overall well-being through a holistic approach, incorporating personalized strategies for physical fitness, mental health, and community integration. Researchers are excited about this program because it promises to address not just the physical, but also the social and emotional aspects of living with SCI, potentially leading to improved quality of life.

What evidence suggests that the Living Longer and Stronger with SCI program is effective for spinal cord injury?

Research has shown that the "Living Longer and Stronger with SCI" program, which participants in this trial may receive, aims to help people with spinal cord injuries improve their health. The program promotes an active lifestyle and self-care, crucial for enhancing physical, mental, and social well-being. Early signs suggest that these health-focused activities can improve quality of life by addressing specific health needs. This program may help participants live healthier, longer lives by encouraging regular exercise and better self-care. Although specific data on this exact program is limited, it is based on proven health improvement methods. ^{2 4 6 7 8}

Who Is on the Research Team?

Susan Robinson-Whelen, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Living Longer and Stronger with SCI

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.

How Is the Trial Designed?

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+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

The Learning Health System for Spinal Cord Injury (LHS-SCI) initiative aims to improve health systems for individuals with spinal cord injuries (SCI) by analyzing the macroeconomic and societal responses across 27 countries, highlighting the need for tailored healthcare solutions.

A strong correlation was found between healthcare system efficiency and national health investment, indicating that simply having more resources does not guarantee better access to care, emphasizing the need for standardized data to address gaps in SCI healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cross-Cultural Societal Response to SCI: Health and Related Systems. Pacheco, D., Gross-Hemmi, MH.[2017]

The ALLRISC program, involving 300 participants, aims to address the inactive lifestyles and secondary health conditions (SHCs) in aging individuals with spinal cord injuries (SCI) through a multidisciplinary approach focused on fitness and quality of life.

Interventions such as self-management programs, low-intensity wheelchair exercise, and hybrid functional electrical stimulation are hypothesized to enhance active lifestyles, prevent SHCs, and improve overall participation and quality of life for those with chronic SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active LifestyLe Rehabilitation interventions in aging spinal cord injury (ALLRISC): a multicentre research program. van der Woude, LH., de Groot, S., Postema, K., 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]

Australians with spinal cord injury (SCI) reported significantly lower physical health scores compared to the general population, indicating a notable impact on their physical functioning and overall health status.

Interestingly, despite the lower physical health ratings, individuals with SCI had higher mental health scores, suggesting that mental well-being may not be as adversely affected as physical health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health status rated with the Medical Outcomes Study 36-Item Short-Form Health Survey after spinal cord injury. Haran, MJ., Lee, BB., King, MT., et al.[2022]

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]

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]

The Spinal Cord Injury Model Systems (SCIMS) program, established in 1970, aims to enhance the health and quality of life for individuals with spinal cord injuries through comprehensive care and research.

This issue of the Archives of Physical Medicine and Rehabilitation presents 24 articles showcasing diverse SCIMS research, covering topics from epidemiology to assistive technology, highlighting the program's extensive contributions to understanding and improving outcomes for spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current research outcomes from the spinal cord injury model systems. Chen, Y., Deutsch, A., DeVivo, MJ., et al.[2011]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06227000

Living Longer and Stronger With Spinal Cord Injury (SCI) 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, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06227000?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Spinal%20Cord%20Injuries))&rank=9

Living Longer and Stronger With Spinal Cord Injury (SCI) 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, ...

3. msktc.org msktc.org/sci/projects/living-longer-and-stronger-spinal-cord-injury-online-program-promoting-healthy-aging

Living Longer and Stronger with Spinal Cord Injury The purpose of the study is to develop and test an online health promotion program for people aging with SCI. Working closely with a community advisory ...

4. scitrialsfinder.net scitrialsfinder.net/trials/NCT06227000

Living Longer and Stronger With Spinal Cord Injury (SC 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, ...

5. withpower.com withpower.com/trial/phase-spinal-cord-injuries-1-2024-2c249

Health Program for Spinal Cord Injury (LLS Trial) 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06227000?cond=Spinal%20Cord%20Injuries&rank=9

Living Longer and Stronger With Spinal Cord Injury (SCI) 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, ...

7. trialx.com trialx.com/clinical-trials/listings/284827/living-longer-and-stronger-with-spinal-cord-injury-sci/

Living Longer and Stronger With Spinal Cord Injury (SCI) 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9936900/

Life Satisfaction Trend and Mortality After Traumatic Spinal ... Individuals with SCI have an increased risk of mortality compared to the general population, and studies suggest that life expectancy for those who survived the ...