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Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication

NCT02341716 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2022-05-06

No results posted yet for this study

Summary

The purpose of this randomized clinical trial is to determine and compare the clinical and cost effectiveness of three methods for exercise therapy as treatment for patients with intermittent claudication. The methods tested are a hospital-based (SET) and a home-based (HET) supervised exercise program and unsupervised walk advice (WA) and all patients are followed for 12 months. Unsupervised WA consists of advice of at least 30 minutes walking with Nordic Poles (NP) at least three times per week and this basic treatment, including best medical treatment, is used in all three treatment groups. In addition to this basic treatment, the SET group patients during the first six months participate in group-based exercise therapy in the hospital for 50 minutes three times weekly, supervised by a physiotherapist. The HET group patients perform the same exercise in their home 50 minutes three times weekly during six months receiving feedback from a physiotherapist by a phone call every 14th day. The SET and HET group patients are recommended to continue the 50 minutes three times weekly exercise therapy in their homes without supervision during the last six months. Primary outcome is change from baseline to 12 months in walking distance during six minutes in a hospital corridor (6MWT) and co-primary outcome is change from baseline to 12 months in health-related quality of life (HRQoL) using the SF36 questionnaire. Secondary outcomes include fulfillment of patient-specified goals with treatment (PSFS), change in health-related quality-of-life (HRQoL) with a disease-specific instrument (VascuQoL), walking impairment as measured by the Walking Impairment Questionnaire, physical activity (accelerometer) and compliance with physical exercise therapy (patient diary).

Conditions

  • Intermittent Claudication

Interventions

PROCEDURE

WA

Walk advice with Nordic Poles and best medical treatment

PROCEDURE

SET

Walk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy

PROCEDURE

HET

Walk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Lennart Jivegård

    lead OTHER

Principal Investigators

  • Lennart Jivegård, MD, Lecturer · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2021-03-31
Completion
2022-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341716 on ClinicalTrials.gov