Improving physical activity after lower limb amputation
Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation
PHASE2 · University of Colorado, Denver · NCT04083456
This study is testing a new walking program to help people who have had a lower limb amputation become more active and improve their health.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04083456 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a walking biobehavioral intervention in enhancing physical activity levels among individuals who have undergone dysvascular lower limb amputation. It addresses the challenges of sedentary lifestyles and disabilities associated with chronic conditions such as diabetes and peripheral artery disease. By leveraging established rehabilitation techniques, the intervention seeks to promote self-management of physical activity and reduce disability in this population. Participants will engage in a structured program designed to encourage walking and improve their overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50-85 who have experienced a lower limb amputation due to diabetes or peripheral artery disease within the past year.
Not a fit: Patients with amputations due to trauma or cancer, or those with significant cognitive impairments or other serious health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and mobility for patients recovering from dysvascular amputations.
How similar studies have performed: Previous studies have shown promise in using behavioral interventions to improve physical activity in similar populations, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Within the age range of 50-85 years * Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD) * Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months * Participant goal of household walking or better using a prosthesis Exclusion Criteria: * Trauma or cancer-related etiology of the LLA * Decisionally challenged individuals (MMSE score below 24) * Prisoners * Active cancer treatment * Recent stroke (within 2 years) * Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.
Where this trial is running
Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Cory Christiansen, PT, PhD — University of Colorado, Denver
- Study coordinator: Eliza A. Biondi, MS
- Email: eliza.biondi@cuanschutz.edu
- Phone: 303-724-6035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, Diabetes Mellitus, Peripheral Artery Disease, Dysvascular Amputation, Diabetes, Physical Activity