Exercise Therapy for PAD Using Mobile Health
Peripheral Artery Disease
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 40 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 63 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. The investigators will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.
Leer la descripción completa
An estimated 8.5 million Americans (or 7% of US adults) and nearly 10% of Veterans are estimated to have peripheral arterial disease (PAD). Significantly debilitating and negatively impacting quality of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors.
Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population's travel to group facilities in the current COVID pandemic.
A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. The goal is of this study is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD.
This technology-enhanced approach for HBET will be conducted by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. This newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device to improve convenience, access, and adherence to HBET for PAD.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Eligible Veteran status
- Clinically stable intermittent claudication (2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
- Established peripheral artery disease (PAD) diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)
- Access to safe location to perform walking exercises
Exclusion Criteria:
- Above or below knee amputation
- critical limb ischemia (rest pain or tissue loss including ulceration or gangrene)
- inability to walk without a walker
- wheelchair confinement
- non-English speaking
- significant visual impairment that interferes with walking activity
- hearing impairment that interferes with full study participation
- unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention
- Individuals whose walking is limited by a condition other than peripheral artery disease (PAD)
- Any active cardiac condition including unstable angina
- unstable atrial or ventricular arrhythmias
- high-grade heart block without a pacemaker
- active myopericarditis
- recent venous thromboembolism
- or recent abnormal baseline stress test suggesting ischemia
- other high-risk findings (e.g., drop of systolic blood \> 20 millimetres of mercury (mmHg) with exercise)
- Presence of Class III NYHA heart failure or CCS III angina
- Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months
- Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)
- neurodegenerative disorders such as Parkinson's Disease that impair walking ability
- cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)
- Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months
- Mental health illness that may interfere with the ability to consent and/or participate in the study, including mini-mental status examination score \<24
- dementia
- active psychiatric disorder such as schizophrenia or bipolar disorder
- history of suicidal or homicidal ideation in the preceding six months
- history of suicidal attempts in the preceding 12 months
- history of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)
- Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider
- Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
- Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)
- Deemed to be poorly suited for the study or the study intervention at the discretion of the principal investigator (PI) or study staff
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Performance evaluation
Preliminary performance evaluation to refine the Smart MOVE! intervention.
Behavioral: Performance evaluation
Smart MOVE!
Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.
Behavioral: Smart MOVE!
Usual care
Participants will receive general walking advice for 12 weeks.
Behavioral: General walking advice
Smart MOVE! BEHAVIORAL
Multi-component behavioral intervention of peripheral artery disease (PAD) consisting of:
1. guideline-directed home-based exercise therapy (HBET) prescription
2. active behavioral coaching (via MOVE! program or other)
3. mobile health monitoring
General walking advice BEHAVIORAL
Basic guidance on performing walking exercises for peripheral artery disease (PAD) according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching.
Performance evaluation BEHAVIORAL
Preliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include:
1. Provider and stakeholder interviews
2. Peripheral artery disease (PAD) patient interviews
2\) N-of-1 trials to refine the intervention
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
6-minute walk test (6MWT)
Plazo: 90 days
The 6MWT is a well-validated measure of functional capacity and increasingly recognized as a meaningful outcome measure in peripheral artery disease (PAD). Participants will be asked to walk back and forth along a 100-foot hallway for six minutes using standard methods and have their total distance recorded
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Atlanta VA Medical and Rehab Center, Decatur, GADecatur, Georgia, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- VA Office of Research and Development
- Inicio del estudio
- 1 dic 2021 Real
- Finalización primaria
- 26 oct 2026 Real
- Finalización del estudio
- 26 oct 2026 Real
- Primera publicación
- 17 may 2021 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026