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

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ClinicalTrials.gov Identifier: NCT02341716
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Lennart Jivegård, Sahlgrenska University Hospital, Sweden

Brief 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).

Condition or disease Intervention/treatment Phase
Intermittent Claudication Procedure: WA Procedure: SET Procedure: HET Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Walk advice
All WA patients receive best medical treatment (BMT) including control of risk factors for arteriosclerosis, simvastatin 40 mg daily, aspirin 75 mg daily and are recommended outdoor walking with Nordic Poles at least 30 minutes at least three times per week. The WA patients are unsupervised during the study period and are followed by a blinded observer at baseline, three, six and 12 months.
Procedure: WA
Walk advice with Nordic Poles and best medical treatment

Active Comparator: Hospital-based supervised exercise
All SET patients receive the same basic treatment as WA patients: best medical treatment (BMT) including control of risk factors for arteriosclerosis, simvastatin 40 mg daily, aspirin 75 mg daily and recommendation of outdoor walking with Nordic Poles at least 30 minutes at least three times per week. The SET group in addition receives three times weekly during six months in-hospital muscle exercise therapy in a group supervised by a physiotherapist. After the six months of supervised exercise therapy, the SET patients are recommended to continue the same muscle exercise therapy at home, but without feedback, between seven and 12 months.
Procedure: SET
Walk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy

Active Comparator: Home-based supervised exercise
All HET patients receive the same basic treatment as WA patients: best medical treatment (BMT) including control of risk factors for arteriosclerosis, simvastatin 40 mg daily, aspirin 75 mg daily and recommendation of outdoor walking with Nordic Poles at least 30 minutes at least three times per week. The HET group patients in addition perform the same muscle exercise therapy three times weekly during six months as the SET patients, but in their homes, and are supervised and given feedback by phone calls every 14th day by a physiotherapist. After six months of supervised exercise therapy, the HET patients are recommended to continue the same muscle exercise therapy, but without feedback, between seven and 12 months.
Procedure: HET
Walk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy




Primary Outcome Measures :
  1. Six-minutes-walk-test walking distance (6MWD) [ Time Frame: Baseline and 12 months, change ]
    Walk test in a hospital corridor where the patient is encouraged to walk as far as possible between two cones, 30 meters apart, during six minutes

  2. Generic health-related quality of life (SF36) [ Time Frame: Baseline and 12 months, change ]
    Short-form 36 is an extensively used and validated generic health-related quality of life instrument


Secondary Outcome Measures :
  1. Disease-specific health-related quality of life (VascuQoL) [ Time Frame: Baseline and 12 months, change ]
    VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.

  2. Walking impairment (Walking Impairment Questionnaire, WIQ) [ Time Frame: Baseline and 12 months, change ]
    The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish

  3. Physical activity [ Time Frame: Baseline and 12 months, change ]
    Physical activity is assessed using an accelerometer (ActivePAL) carried by the patient during one week adhered to the thigh and covered with a plastic foil to allow a shower. The ActivePAL gives continuous data (e.g. standing, sitting, walking) regarding physical activity and is validated for use in patients with intermittent claudication

  4. Compliance to exercise therapy [ Time Frame: 12 months ]
    Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)

  5. HbA1c and serum lipids [ Time Frame: Baseline and 12 months, change ]
    Standard blood tests

  6. Ankle-brachial-index (ABI) [ Time Frame: Baseline and 12 months, change ]
    The highest pressure at the ipsilateral ankle level divided by the simultaneously measured arm blood pressure

  7. Patient-specified goals with treatment (PSFS) [ Time Frame: 12 months ]
    At baseline, the patient specifies one to five goals with the treatment for intermittent claudication and fulfillment of these goals is quantified by the patient during follow-up

  8. Cardiovascular events [ Time Frame: 12 months ]
    Cardiovascular adverse events, minor and major, during the course of the study

  9. Muscular-skeletal events [ Time Frame: 12 months ]
    Muscular-skeletal events, minor and major, during the course of the study

  10. Vascular surgical revascularization [ Time Frame: 12 months ]
    Invasive vascular procedure in the lower limb(s) during the course of the study

  11. Six-minutes-walk-test walking distance (6MWD) [ Time Frame: Baseline and three months, change ]
    Walk test in a hospital corridor where the patient is encouraged to walk as far as possible between two cones, 30 meters apart, during six minutes

  12. Six-minutes-walk-test walking distance (6MWD) [ Time Frame: Baseline and six months, change ]
    Walk test in a hospital corridor where the patient is encouraged to walk as far as possible between two cones, 30 meters apart, during six minutes

  13. Six-minutes-walk-test walking distance (6MWD) [ Time Frame: Six and 12 months, change ]
    Walk test in a hospital corridor where the patient is encouraged to walk as far as possible between two cones, 30 meters apart, during six minutes

  14. Generic health-related quality of life (SF36) [ Time Frame: Baseline and three months, change ]
    Short-form 36 is an extensively used and validated generic health-related quality of life instrument

  15. Generic health-related quality of life (SF36) [ Time Frame: Baseline and six months, change ]
    Short-form 36 is an extensively used and validated generic health-related quality of life instrument

  16. Generic health-related quality of life (SF36) [ Time Frame: Six and 12 months, change ]
    Short-form 36 is an extensively used and validated generic health-related quality of life instrument

  17. Disease-specific health-related quality of life (VascuQoL) [ Time Frame: Baseline and three months, change ]
    VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.

  18. Disease-specific health-related quality of life (VascuQoL) [ Time Frame: Baseline and six months, change ]
    VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.

  19. Disease-specific health-related quality of life (VascuQoL) [ Time Frame: Six and 12 months, change ]
    VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.

  20. Walking impairment (Walking Impairment Questionnaire, WIQ) [ Time Frame: Baseline and three months, change ]
    The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish

  21. Walking impairment (Walking Impairment Questionnaire, WIQ) [ Time Frame: Baseline and six months, change ]
    The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish

  22. Walking impairment (Walking Impairment Questionnaire, WIQ) [ Time Frame: Six and 12 months, change ]
    The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish

  23. Physical activity [ Time Frame: Baseline and three months, change ]
    Physical activity is assessed using an accelerometer (ActivePAL) carried by the patient during one week adhered to the thigh and covered with a plastic foil to allow a shower. The ActivePAL gives continuous data (e.g. standing, sitting, walking) regarding physical activity and is validated for use in patients with intermittent claudication

  24. Physical activity [ Time Frame: Baseline and six months, change ]
    Physical activity is assessed using an accelerometer (ActivePAL) carried by the patient during one week adhered to the thigh and covered with a plastic foil to allow a shower. The ActivePAL gives continuous data (e.g. standing, sitting, walking) regarding physical activity and is validated for use in patients with intermittent claudication

  25. Physical activity [ Time Frame: Six and 12 months, change ]
    Physical activity is assessed using an accelerometer (ActivePAL) carried by the patient during one week adhered to the thigh and covered with a plastic foil to allow a shower. The ActivePAL gives continuous data (e.g. standing, sitting, walking) regarding physical activity and is validated for use in patients with intermittent claudication

  26. Compliance to exercise therapy [ Time Frame: Three months ]
    Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)

  27. Compliance to exercise therapy [ Time Frame: Six months ]
    Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)

  28. Patient-specified goals with treatment (PSFS) [ Time Frame: Six months ]
    At baseline, the patient specifies one to five goals with the treatment for intermittent claudication and fulfillment of these goals is quantified by the patient during follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341716


Contacts
Contact: Lennart Jivegård, MD, Lecturer +46313427486 lennart.jivegard@vgregion.se
Contact: Joakim Nordanstig, MD, PhD +46313421000 joakim.nordanstig@vgregion.se

Locations
Sweden
Södra Älvsborgs Hospital Recruiting
Borås, Västra Götaland, Sweden, 50182
Contact: Christer Drott, MD    +46336161000    christer.drott@vgregion.se   
Contact: Inga-Lill Bengtsson, RN    +46336161000    inga-lill.bengtsson@vgregion.se   
Sub-Investigator: Karin Ludwigs, MD         
Sub-Investigator: Mårten Falkenberg, MD         
Sub-Investigator: Ann-Sofie Adler, RPT         
Sub-Investigator: Emma Dahlman, RPT         
Sub-Investigator: Inga-Lill Bengtsson, RN         
Sub-Investigator: Jo Wennerås, MD         
Sub-Investigator: Erika Nygren, RN         
Sub-Investigator: Erica Lopez, RN         
Sahlgrenska University Hospital Recruiting
Göteborg, Västra Götaland, Sweden, 41345
Contact: Lennart Jivegard, MD    +46313421000    lennart.jivegard@vgregion.se   
Contact: Joakim Nordanstig, MD    +46313421000    joakim.nordanstig@vgregion.se   
Sub-Investigator: Marcus Langenskiöld, MD         
Sub-Investigator: Marlene Hensäter, RN         
Sub-Investigator: Monika Broeren, RN         
Sub-Investigator: Maria Bäck, RPT         
Sub-Investigator: Åsa Cider, RPT         
Sub-Investigator: Anna MH Johansson, RPT         
Sub-Investigator: Jenny Snickars, RPT         
Sponsors and Collaborators
Lennart Jivegård
Vastra Gotaland Region
Investigators
Principal Investigator: Lennart Jivegård, MD, Lecturer Sahlgrenska University Hospital, Sweden

Responsible Party: Lennart Jivegård, MD, University lecturer, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02341716     History of Changes
Other Study ID Numbers: SahlgrenskaUH
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Lennart Jivegård, Sahlgrenska University Hospital, Sweden:
intermittent claudication
exercise therapy
physiotherapy

Additional relevant MeSH terms:
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms