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

Primary Purpose

Intermittent Claudication

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
WA
SET
HET
Sponsored by
Lennart Jivegård
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring intermittent claudication, exercise therapy, physiotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Södra Älvsborgs Hospital
  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Walk advice

Hospital-based supervised exercise

Home-based supervised exercise

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Six-minutes-walk-test walking distance (6MWD)
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
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument

Secondary Outcome Measures

Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Physical activity
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
Compliance to exercise therapy
Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)
HbA1c and serum lipids
Standard blood tests
Ankle-brachial-index (ABI)
The highest pressure at the ipsilateral ankle level divided by the simultaneously measured arm blood pressure
Patient-specified goals with treatment (PSFS)
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
Cardiovascular events
Cardiovascular adverse events, minor and major, during the course of the study
Muscular-skeletal events
Muscular-skeletal events, minor and major, during the course of the study
Vascular surgical revascularization
Invasive vascular procedure in the lower limb(s) during the course of the study
Six-minutes-walk-test walking distance (6MWD)
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
Six-minutes-walk-test walking distance (6MWD)
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
Six-minutes-walk-test walking distance (6MWD)
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
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Physical activity
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
Physical activity
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
Physical activity
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
Compliance to exercise therapy
Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)
Compliance to exercise therapy
Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)
Patient-specified goals with treatment (PSFS)
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

Full Information

First Posted
January 12, 2015
Last Updated
May 5, 2022
Sponsor
Lennart Jivegård
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT02341716
Brief Title
Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication
Acronym
SUNFIT
Official Title
Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lennart Jivegård
Collaborators
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Background Intermittent claudication is usually caused by atherosclerotic stenoses and/or occlusions in the arteries to the legs and affects 7% of the Swedish population aged 60 years or more. Evidence-based treatment is best medical treatment (BMT) and exercise therapy. Best medical treatment includes treatment of risk factors for arteriosclerosis. Regarding exercise therapy, in-hospital supervised exercise therapy (SET) on a graded treadmill is known to improve walking performance as measured on the graded treadmill after three and six months. There is only scarce data on long-term results and very limited data regarding improvement of health related quality of life (HRQoL) by SET. In most countries, walk advice (WA) is routine clinical practice and resources for SET are often lacking. Invasive treatment (surgical or endovascular) is rarely required for patients with intermittent claudication. New techniques (GPS and accelerometers) enable measurement of physical activity and training in home environment. The use of such techniques could facilitate home-based (HET) instead of hospital-based supervised exercise (SET) therapy by providing the caregiver data that could be used for feedback to the patient in order to obtain optimal patient benefit by the exercise therapy. This raises hope that results of and the long-term compliance to exercise therapy may improve. Aim: in patients with intermittent claudication (IC) who do not require invasive treatment evaluate walking performance, HRQoL, fulfillment of patient-defined goals with treatment, walking impairment, long-term compliance to exercise therapy, physical activity and cost-effectiveness for different exercise therapy modalities in order to define the most effective and cost effective treatment. One hundred and sixty-five IC patients requesting treatment for their IC symptoms in the vascular surgical departments of Sahlgrenska University Hospital and Södra Älvsborg Hospital, Sweden and in whom invasive treatment is not considered necessary are randomized (computerized adaptive stratified randomization) to WA with Nordic Poles (NP) + best medical treatment (BMT), or WA with NP + BMT + SET, or WA with NP + BMT + HET All randomized patients are recommended outdoor walking with NP at least 30 minutes at least three times per week. The SET group in addition receives in-hospital muscle exercise therapy in a group supervised by a physiotherapist three times weekly during six months. The HET group patients perform the same muscle exercise therapy at home with feedback every 14th day from a physiotherapist during six months. After the six months of supervised exercise therapy, the SET and HET patients are recommended to continue the same muscle exercise therapy at home, but without feedback, between seven and 12 months. The patients are followed by a blinded observer (physiotherapist unaware of the patient´s randomized group) at three, six and 12 months. Primary outcome: change from baseline to 12 months in walking distance during six-minutes-walk-test (6MWT) and co-primary outcome: change from baseline to 12 months in health-related quality of life (SF36). Secondary outcomes: walking impairment as measured by the Walking Impairment Questionnaire (WIQ), fulfillment of patient-defined goals (Patient-Specific-Functional Scale), physical activity (accelerometer), compliance to exercise therapy (patient diary), disease-specific HRQoL (VascuQol) and cost-effectiveness. Also change over time (baseline to three, baseline to six and six to 12 months) is studied. It is important to determine whether the supervised exercise therapy modalities (SET and HET) have equivalent results and are better than WA with NP and BMT alone. The trial is designed to answer the question whether HET is not significantly less clinically effective as SET and whether SET is more clinically effective than WA with NP and BMT. The study started in September 2014, inclusion is expected to stop in September 2016 and end of follow-up is September 2017.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
intermittent claudication, exercise therapy, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walk advice
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hospital-based supervised exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home-based supervised exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
WA
Intervention Description
Walk advice with Nordic Poles and best medical treatment
Intervention Type
Procedure
Intervention Name(s)
SET
Intervention Description
Walk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy
Intervention Type
Procedure
Intervention Name(s)
HET
Intervention Description
Walk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy
Primary Outcome Measure Information:
Title
Six-minutes-walk-test walking distance (6MWD)
Description
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
Time Frame
Baseline and 12 months, change
Title
Generic health-related quality of life (SF36)
Description
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Time Frame
Baseline and 12 months, change
Secondary Outcome Measure Information:
Title
Disease-specific health-related quality of life (VascuQoL)
Description
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Time Frame
Baseline and 12 months, change
Title
Walking impairment (Walking Impairment Questionnaire, WIQ)
Description
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Time Frame
Baseline and 12 months, change
Title
Physical activity
Description
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
Time Frame
Baseline and 12 months, change
Title
Compliance to exercise therapy
Description
Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)
Time Frame
12 months
Title
HbA1c and serum lipids
Description
Standard blood tests
Time Frame
Baseline and 12 months, change
Title
Ankle-brachial-index (ABI)
Description
The highest pressure at the ipsilateral ankle level divided by the simultaneously measured arm blood pressure
Time Frame
Baseline and 12 months, change
Title
Patient-specified goals with treatment (PSFS)
Description
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
Time Frame
12 months
Title
Cardiovascular events
Description
Cardiovascular adverse events, minor and major, during the course of the study
Time Frame
12 months
Title
Muscular-skeletal events
Description
Muscular-skeletal events, minor and major, during the course of the study
Time Frame
12 months
Title
Vascular surgical revascularization
Description
Invasive vascular procedure in the lower limb(s) during the course of the study
Time Frame
12 months
Title
Six-minutes-walk-test walking distance (6MWD)
Description
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
Time Frame
Baseline and three months, change
Title
Six-minutes-walk-test walking distance (6MWD)
Description
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
Time Frame
Baseline and six months, change
Title
Six-minutes-walk-test walking distance (6MWD)
Description
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
Time Frame
Six and 12 months, change
Title
Generic health-related quality of life (SF36)
Description
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Time Frame
Baseline and three months, change
Title
Generic health-related quality of life (SF36)
Description
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Time Frame
Baseline and six months, change
Title
Generic health-related quality of life (SF36)
Description
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Time Frame
Six and 12 months, change
Title
Disease-specific health-related quality of life (VascuQoL)
Description
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Time Frame
Baseline and three months, change
Title
Disease-specific health-related quality of life (VascuQoL)
Description
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Time Frame
Baseline and six months, change
Title
Disease-specific health-related quality of life (VascuQoL)
Description
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Time Frame
Six and 12 months, change
Title
Walking impairment (Walking Impairment Questionnaire, WIQ)
Description
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Time Frame
Baseline and three months, change
Title
Walking impairment (Walking Impairment Questionnaire, WIQ)
Description
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Time Frame
Baseline and six months, change
Title
Walking impairment (Walking Impairment Questionnaire, WIQ)
Description
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Time Frame
Six and 12 months, change
Title
Physical activity
Description
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
Time Frame
Baseline and three months, change
Title
Physical activity
Description
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
Time Frame
Baseline and six months, change
Title
Physical activity
Description
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
Time Frame
Six and 12 months, change
Title
Compliance to exercise therapy
Description
Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)
Time Frame
Three months
Title
Compliance to exercise therapy
Description
Compliance to exercise therapy is assessed by a patient diary in which the patients register all exercise activities (SET and HET groups only)
Time Frame
Six months
Title
Patient-specified goals with treatment (PSFS)
Description
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
Time Frame
Six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Symptom duration > 6 months. Intermittent claudication is the walk limiting condition. Exclusion Criteria: Invasive treatment for intermittent claudication performed within three months Invasive treatment for intermittent claudication considered necessary within 12 months Inability to understand Swedish, answer questionnaires or perform walk test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Jivegård, MD, Lecturer
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södra Älvsborgs Hospital
City
Borås
State/Province
Västra Götaland
ZIP/Postal Code
50182
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
State/Province
Västra Götaland
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31147129
Citation
Sandberg A, Cider A, Jivegard L, Nordanstig J, Wittboldt S, Back M. Test-retest reliability, agreement, and minimal detectable change in the 6-minute walk test in patients with intermittent claudication. J Vasc Surg. 2020 Jan;71(1):197-203. doi: 10.1016/j.jvs.2019.02.056. Epub 2019 May 27.
Results Reference
derived

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

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