Observational Feasibility Study of Home-based Training With Therabands in PAD-patients

Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04043546

Enrollment

Registered

2019-08-02

Start date

2017-10-01

Completion date

2018-09-30

Last updated

2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication, Peripheral Artery Disease

Brief summary

The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.

Interventions

BEHAVIORALaerobic+resistance exercise training program

Personalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Patients enrolled in the study receive a novel physiotherapy program.

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Inclusion criteria

* age ≥ 50 yrs; * ankle-brachial index (ABI) ≤ 0.9 in one or two legs; * Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated); * body mass index \<35 kg/m 2 ; * resting systolic blood pressure (BP) \<160 mmHg and diastolic BP \<105 mmHg; * ability to walk at least 2 min at 2.0 mph; * ability to undertake an incremental treadmill test; * decrease of at least 15% in ABI after a maximal treadmill test; * not currently engaging in any regular exercise program.

Exclusion criteria

* exercise induced signs of myocardial ischemia or complex ventricular arrhythmias; * no access to laptop or internet; * no medical clearance for exercise

Design outcomes

Primary

Measure	Time frame	Description
user satisfaction	4 weeks	self-developed questionnaire based evaluation of user satisfaction
walking distance	4 weeks	pain free and maximal walking distance are recorded using the Gardner treadmill protocol.

Secondary

Measure	Time frame	Description
Physical activity	2 months	Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026