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

Peripheral Artery Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043546
• Other study ID #: PAD-feasibility
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: August 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• aerobic+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.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	user satisfaction	self-developed questionnaire based evaluation of user satisfaction	4 weeks
Primary	walking distance	pain free and maximal walking distance are recorded using the Gardner treadmill protocol.	4 weeks
Secondary	Physical activity	Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.	2 months