Walking Intervention for Post-Amputation Care

(DASH Trial)

Overseen By Eliza A. Biondi, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Disqualifiers: Cancer, Stroke, Cognitive impairment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special walking program improves mobility in individuals who have lost a lower leg due to poor blood flow. Participants will receive biobehavioral training, which combines regular physical therapy with behavior and lifestyle sessions, primarily conducted through telehealth. The trial seeks individuals who have undergone a lower-leg amputation in the past year due to Type II Diabetes or Peripheral Artery Disease and wish to enhance their walking ability with a prosthetic. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important research.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that participants generally find the walking program easy to handle. Studies on similar programs for individuals recovering from nontraumatic amputations have not identified any major problems, suggesting this approach is safe.

As this trial is in an early stage, much remains to be learned about the treatment's safety. However, past research is encouraging, as it has not revealed any significant safety issues. Participants in earlier studies responded well to the treatment, which is promising for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Walking Biobehavioral Intervention for post-amputation care because it integrates biobehavioral training with conventional outpatient rehabilitation, providing a holistic approach to recovery. Unlike standard care, which usually focuses solely on physical rehabilitation, this intervention incorporates psychological and behavioral support through ten sessions, including telehealth, over five months. This unique combination aims to improve patients' mobility and mental well-being, potentially leading to a more comprehensive recovery process.

What evidence suggests that the Walking Biobehavioral Intervention is effective for improving physical activity after lower limb amputation?

Research has shown that the Walking Biobehavioral Intervention, which participants in this trial may receive, can help individuals with lower limb amputations due to blood flow issues walk more. Studies have found that this intervention increases walking ability and reduces inactive time. For older veterans with nontraumatic amputations, this method effectively changed physical activity habits. Additionally, lifestyle interventions like this have improved physical fitness, walking skills, and overall quality of life for those with amputations. These findings suggest that the intervention could increase physical activity after an amputation. ^{1 3 4 6 7}

Who Is on the Research Team?

Cory Christiansen, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults aged 50-85 who've had a lower-limb amputation within the last year due to diabetes or peripheral artery disease. They should aim to walk using a prosthesis and not be undergoing active cancer treatment, have had trauma or cancer-related limb loss, recent stroke, cognitive challenges, or any condition making it unsafe to participate as judged by the study leader.

Inclusion Criteria

I am between 50 and 85 years old.

I have been diagnosed with Type II Diabetes and/or Peripheral Artery Disease.

I had a lower-limb amputation above or below the knee in the last year.

Exclusion Criteria

Prisoners

I am currently receiving treatment for cancer.

My lower limb amputation was due to trauma or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conventional Prosthetic Rehabilitation

Participants undergo conventional prosthetic rehabilitation as part of the intervention

3 months

10 sessions (in-person)

Biobehavioral Intervention

Participants receive biobehavioral training integrated into conventional outpatient training

5 months

1 combined session (in-person), 9 sessions (telehealth)

Follow-up

Participants are monitored for maintenance of physical activity and other outcomes

6 months

No-contact phase with FitBit monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Walking Biobehavioral Intervention

Trial Overview The study is testing if a walking biobehavioral intervention can help improve physical activity in people after losing a limb below the knee due to poor blood flow or diabetes. Participants will either receive this special walking program or an attention control which serves as a comparison.

How Is the Trial Designed?

Group I: Walking Biobehavioral Intervention (EXP) Experimental Treatment 1 Intervention

The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.

Group II: Attention Control (CTL) Active Control 1 Intervention

The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).

Walking Biobehavioral Intervention is already approved in United Kingdom for the following indications:

Approved in United Kingdom as Walking Biobehavioral Intervention for:

• Improving physical activity after dysvascular lower limb amputation
• Managing intermittent claudication in peripheral artery disease

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A review of 16 studies on interventions for increasing physical activity in individuals with lower limb amputation found that both behavioral and prosthetic approaches had similar methodological quality but mixed results in effectiveness.

There is a lack of comprehensive studies on the efficacy of behavioral interventions, and prosthetic interventions may require more advanced technology to achieve significant improvements in physical activity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Physical Activity Outcomes in Rehabilitation Interventions for Lower Limb Amputees: a Systematic Review. Jamieson, AG., Murray, L., Buis, A.[2023]

Lifestyle interventions that focus on physical activity and stress management can effectively improve physical fitness, walking capacity, and quality of life for individuals with lower limb amputations, based on a review of 13 studies.

Despite these positive outcomes, the overall methodological quality of the studies was limited, suggesting that further research is needed to confirm these findings and explore additional lifestyle factors like nutrition and smoking habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of (Active) Lifestyle Interventions in People With a Lower Limb Amputation: A Systematic Review. Van Helm, S., Krops, LA., Dekker, R., et al.[2022]

A short, intensive physiotherapy program significantly improved walking ability and weight-bearing capacity in 58 male unilateral lower limb amputees compared to usual care, with notable results in the 2-minute walk test and physiological cost index.

The study highlights the effectiveness of targeted physiotherapy in enhancing functional performance for amputees, suggesting that such programs should be integrated into rehabilitation practices, even in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of physiotherapy rehabilitation on functional performance of lower limb amputees. Rau, B., Bonvin, F., de Bie, R.[2015]

Gait training interventions, both overground and treadmill-based, are essential for lower extremity amputees to address gait asymmetries and improve overall biomechanics, as supported by a systematic review of 18 studies.

Overground training combined with various feedback methods and treadmill training with visual feedback or body weight support were found to significantly enhance gait performance, including improvements in walking distance and movement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review. Highsmith, MJ., Andrews, CR., Millman, C., et al.[2020]

A 10-month rehabilitation program for nine transfemoral amputees significantly improved their walking speeds, with comfortable gait speed increasing from 0.95 m/s to 1.40 m/s and brisk speed from 1.29 m/s to 1.65 m/s, and these improvements were maintained at a 6-month follow-up.

The program not only eliminated the need for walking aids among participants but also reduced low-back pain, with seven participants even learning to jog, suggesting enhanced mobility and quality of life through this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait improvement in unilateral transfemoral amputees by a combined psychological and physiotherapeutic treatment. Sjödahl, C., Jarnlo, GB., Persson, BM.[2019]

Behavior change interventions can significantly improve health outcomes and quality of life for individuals with chronic conditions like obesity, type 2 diabetes, and heart disease.

The review emphasizes the importance of developing effective, scalable interventions and introduces a user-friendly framework to guide the decision-making process in creating these behavior change strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview. Araújo-Soares, V., Hankonen, N., Presseau, J., et al.[2021]

People with lower-limb loss (PLL) take an average of 5087 steps per day, which is significantly lower than the recommended 10,000 steps for general health, indicating a need for increased physical activity in this population.

The review identified 21 studies involving 515 participants, primarily focusing on transtibial amputations, and highlighted gaps in research regarding physical activity levels and the need for larger, more defined studies to better understand and improve activity in PLL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Activity in People With Lower-Limb Loss: 10,000 Steps Per Day? Wong, CK., Rissland, MS., Madagan, DM., et al.[2021]

Biofeedback systems have been shown to effectively improve gait rehabilitation in individuals with lower-limb amputation, as highlighted by a systematic review of 31 studies.

The most effective biofeedback methods focus on limb loading and symmetry, with visual feedback being the most commonly used, although challenges remain in usability, especially for elderly users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback Systems for Gait Rehabilitation of Individuals with Lower-Limb Amputation: A Systematic Review. Escamilla-Nunez, R., Michelini, A., Andrysek, J.[2022]

A 12-month telephone-delivered intervention for patients with Type 2 diabetes significantly increased physical activity by 26% compared to only 10% in the usual care group, demonstrating its effectiveness in promoting behavior change.

Patients receiving the intervention also showed improved psychological well-being, a reduction in HbA1c levels (indicating better glycemic control), and a decrease in cardiovascular risk, highlighting the intervention's positive impact on overall health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes. Döbler, A., Herbeck Belnap, B., Pollmann, H., et al.[2020]

The biomedical disease model has shown limited success in treating chronic health conditions, highlighting the need for medical education to evolve in addressing behavior-related diseases.

Enhancing medical education through a focus on patient-centered care, effective communication, and individualized training can better prepare physicians to promote health behavior change and tackle complex health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing Physicians for the 21 Century: Targeting Communication Skills and the Promotion of Health Behavior Change. Sibille, K., Greene, A., Bush, JP.[2021]

A brief motivational interviewing-based health behavior change counseling (HBCC) intervention significantly increased patient participation in rehabilitation after surgery for degenerative lumbar spinal stenosis, leading to higher attendance in physical therapy and home exercise programs.

Patients who received the HBCC intervention showed better functional outcomes at both 3 and 6 months post-surgery, with significant reductions in disability and improvements in health status compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health behavior change counseling in surgery for degenerative lumbar spinal stenosis. Part I: improvement in rehabilitation engagement and functional outcomes. Skolasky, RL., Maggard, AM., Li, D., et al.[2022]

In a study of 112 patients who participated in a 6-session telephone-based cognitive-behavioral physical therapy (CBPT) program after spine surgery, those who met their personalized rehabilitation goals showed significant improvements in physical function at both 6 and 12 months post-surgery.

Goal attainment was linked to better recovery outcomes, emphasizing the importance of setting and achieving specific rehabilitation goals in enhancing physical function after spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Goals After Lumbar Spine Surgery: A Secondary Analysis of Cognitive-Behavioral-Based Physical Therapy Outcomes From a Randomized Controlled Trial. Coronado, RA., Master, H., Bley, JA., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6215727/

Behavior-change intervention targeting physical function ... The behavior-change intervention demonstrates promise for increasing walking activity for people with dysvascular TTA.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32248638/

Biobehavioral Intervention Targeting Physical Activity ... Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial · Abstract.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04083456?draw=2&rank=1

Dysvascular Amputation Self-Management of Health ... The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation. Detailed ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999318302843

Behavior-Change Intervention Targeting Physical Function ... Behavior-change intervention did not improve physical function after dysvascular transtibial amputation. •. Walking activity increased and sedentary time ...

5. archives-rrct.org archives-rrct.org/article/S2590-1095(22)00035-0/fulltext

Effectiveness of (Active) Lifestyle Interventions in People With ... These interventions seemed effective for improving physical fitness, walking capacity, changes in body mass, quality of life, and intensity of physical activity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8229675/

Biobehavioral Intervention Targeting Physical Activity ... Home-based behavior change intervention to promote exercise, walking activity, and disease self-management has been piloted in people recovering from ...

7. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0326761&type=printable

A behaviour change intervention promoting physical activity ... This study will inform the design of a definitive RCT to determine the effectiveness of a peer-led physical activity intervention for people ...