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Register:	ClinicalTrials.gov
Last refreshed on:	16 May 2022
Main ID:	NCT02341716
Date of registration:	12/01/2015
Prospective Registration:	No
Primary sponsor:	Lennart Jivegård
Public title:	Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication SUNFIT
Scientific title:	Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
Date of first enrolment:	September 2014
Target sample size:	165
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02341716
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Sweden

Contacts

Name:	Lennart Jivegård, MD, Lecturer
Address:
Telephone:
Email:
Affiliation:	Sahlgrenska University Hospital, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Intermittent claudication in one or both legs with a typical history and
ankle-brachial-index (ABI) 0.90 or less and/or 30% or more post-exercise reduction of
ABI.

2. Symptom duration > 6 months.

3. Intermittent claudication is the walk limiting condition.

Exclusion Criteria:

1. Invasive treatment for intermittent claudication performed within three months

2. Invasive treatment for intermittent claudication considered necessary within 12 months

3. Inability to understand Swedish, answer questionnaires or perform walk test

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intermittent Claudication

Intervention(s)

Procedure: HET

Procedure: SET

Procedure: WA

Primary Outcome(s)

Six-minutes-walk-test walking distance (6MWD) [Time Frame: Baseline and 12 months, change]

Generic health-related quality of life (SF36) [Time Frame: Baseline and 12 months, change]

Secondary Outcome(s)

Disease-specific health-related quality of life (VascuQoL) [Time Frame: Baseline and three months, change]

Patient-specified goals with treatment (PSFS) [Time Frame: Six months]

Walking impairment (Walking Impairment Questionnaire, WIQ) [Time Frame: Baseline and 12 months, change]

Walking impairment (Walking Impairment Questionnaire, WIQ) [Time Frame: Six and 12 months, change]

Compliance to exercise therapy [Time Frame: 12 months]

Disease-specific health-related quality of life (VascuQoL) [Time Frame: Six and 12 months, change]

Compliance to exercise therapy [Time Frame: Three months]

Physical activity [Time Frame: Six and 12 months, change]

Generic health-related quality of life (SF36) [Time Frame: Baseline and three months, change]

Vascular surgical revascularization [Time Frame: 12 months]

Disease-specific health-related quality of life (VascuQoL) [Time Frame: Baseline and six months, change]

Generic health-related quality of life (SF36) [Time Frame: Six and 12 months, change]

Ankle-brachial-index (ABI) [Time Frame: Baseline and 12 months, change]

Physical activity [Time Frame: Baseline and six months, change]

Six-minutes-walk-test walking distance (6MWD) [Time Frame: Baseline and six months, change]

Walking impairment (Walking Impairment Questionnaire, WIQ) [Time Frame: Baseline and six months, change]

Disease-specific health-related quality of life (VascuQoL) [Time Frame: Baseline and 12 months, change]

Generic health-related quality of life (SF36) [Time Frame: Baseline and six months, change]

Six-minutes-walk-test walking distance (6MWD) [Time Frame: Six and 12 months, change]

HbA1c and serum lipids [Time Frame: Baseline and 12 months, change]

Physical activity [Time Frame: Baseline and 12 months, change]

Patient-specified goals with treatment (PSFS) [Time Frame: 12 months]

Cardiovascular events [Time Frame: 12 months]

Compliance to exercise therapy [Time Frame: Six months]

Muscular-skeletal events [Time Frame: 12 months]

Physical activity [Time Frame: Baseline and three months, change]

Six-minutes-walk-test walking distance (6MWD) [Time Frame: Baseline and three months, change]

Walking impairment (Walking Impairment Questionnaire, WIQ) [Time Frame: Baseline and three months, change]

Secondary ID(s)

SahlgrenskaUH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vastra Gotaland Region

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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