Cardiovascular Diseases Clinical Trial
Official title:
Increasing Activity in Peripheral Arterial Disease
Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.
Lower extremity PAD affects between 10% and 15% of people over the age of 65. A person's
risk for PAD increases with age but can also be raised by smoking or having diabetes, high
blood pressure, high cholesterol, or heart disease. PAD symptoms may include leg pain, foot
or toe wounds, and a noticeably lower temperature in the lower legs than in the rest of the
body. The specific functional impairments caused by PAD symptoms are associated with
increased risks of disability, nursing home placement, mobility loss, hospitalization, and
mortality. Supervised exercise rehabilitation programs have been shown to improve walking
ability in people with PAD. However, few people with PAD have access to supervised exercise
rehabilitation programs because of costs and difficulty traveling to the exercise facility.
Home-based exercise programs may be more beneficial than supervised programs in improving
lower extremity functioning in people with PAD, but more information is needed to support
the effectiveness of at-home rehabilitation. This study will compare the effectiveness of a
home-based GMCB exercise program versus general health education sessions in helping people
with lower extremity PAD to increase their walking frequency and improve their lower leg
functioning.
Participation in this study will last 12 months. The primary outcome will be measured at 6
month follow-up. All participants will undergo a baseline 6-minute walk test on a treadmill
and an electrocardiogram (ECG). They will also provide information on their physical
activity levels. Participants will then be assigned randomly to receive GMCB sessions or
health education sessions. Both groups will attend weekly sessions of their assigned
treatment for a 6 month period. During the GMCB sessions, participants will be asked to
exercise by walking around a track. There will also be a group discussion, led by a
facilitator, who will help participants find ways to increase the frequency of their walking
exercise at home. Each GMCB session will last approximately 60 to 75 minutes. Health
education sessions will last 60 minutes and will cover health-related topics.
After completing approximately 6 months of treatment, participants in both groups will be
telephoned regularly by a study coordinator: they will receive telephone calls every other
week during Months 6 to 9 of follow-up and monthly during Months 9 to 12 of follow-up.
Participants will be asked to return for follow-up testing at Month 6 and Month 12; outcomes
measured at Month 6 are highest priority.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|