Clinical trial NCT04751890: Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial
Official title: Effectiveness of a Home-based Structured Exercise Program Versus Walking Advice in Patients With Peripheral Artery Disease: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: exercise
rehabilitation
exercise testing
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (PAD) and claudication to be implemented in real-world care.

This randomized-controlled trial aims to test the effects on mobility, hemodynamics and cardiovascular outcomes of a structured home-based exercise program (SHB) compared to walking advice (WA) recommendation intended as usual care, in PAD patients.

Male and females PAD patients at Leriche-Fontaine's stage II and aged more than 60 years old will be enrolled. Patients will be randomized in SHB or WA groups.

Patients of SHB group will receive a prescription of a home-based walking program during serial testing sessions at the hospital. The program will include two 10-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. Two follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence and to update the exercise program by increasing the walking speed.

Patients randomized in WA group will receive the advice to walk as suggested by the guidelines. In particular, patients will be recommended to gather almost 30 minutes of walking at least 3 times per week; when they will face claudication pain, they will be allowed to rest and restart walking as soon as possible.

Outcome measures will be performed at the entry prior to randomization, at the end of exercise programs (6-month) and after 12-month follow up. Primary outcomes will be the pain-free walking distance and the 6-minute walking distance collected during the 6-minute walking test Secondary outcomes will include ankle-brachial index, quality of life, lower limb strength and long-term clinical outcomes including revascularization and mortality.


Eligibility criteria: Inclusion Criteria:

* male and females aged \> 60 years old
* peripheral artery disease at Leriche-Fontaine's stage 2a or 2b
* cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.

Exclusion Criteria:

* peripheral artery disease at Leriche-Fontaine's stage 1
* peripheral artery disease at Leriche-Fontaine's stage 3 or more
* severe cardio-respiratory conditions (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV)
* neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.
* very good exercise capacity determined by a 6-minute walking distance \> 500 meters.

Primary outcomes:
measure: 6-Minute Walking Test (mobility)
timeFrame: Change at 6-month (end of training) respect to baseline
Secondary outcomes:
measure: Ankle Brachial Index (hemodynamics)
timeFrame: Change at 6-month (end of training) respect to baseline
measure: Vascu-QoL-6 (health-related quality of life)
timeFrame: Change at 6-month (end of training) respect to baseline
measure: 5-time sit-to-stand test (lower limbs strength)
timeFrame: Change at 6-month (end of training) respect to baseline
measure: Foot temperature
timeFrame: Change at 6-month (end of training) respect to baseline
measure: Number and rate of hospitalizations
timeFrame: 6-month, 12-month and 24-month (follow up)
measure: Number and rate of mortality
timeFrame: 6-month, 12-month and 24-month (follow up)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
Study officials:
affiliation: University of Ferrara and University Hospital of Ferrara
name: Fabio Manfredini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manfredini F, Malagoni AM, Mascoli F, Mandini S, Taddia MC, Basaglia N, Manfredini R, Conconi F, Zamboni P. Training rather than walking: the test in -train out program for home-based rehabilitation in peripheral arteriopathy. Circ J. 2008 Jun;72(6):946-52. doi: 10.1253/circj.72.946.
citation: Treat-Jacobson D, McDermott MM, Bronas UG, Campia U, Collins TC, Criqui MH, Gardner AW, Hiatt WR, Regensteiner JG, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Jan 22;139(4):e10-e33. doi: 10.1161/CIR.0000000000000623. No abstract available.
citation: Manfredini F, Lamberti N, Traina L, Zenunaj G, Medini C, Piva G, Straudi S, Manfredini R, Gasbarro V. Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial. Methods Protoc. 2021 May 10;4(2):29. doi: 10.3390/mps4020029.