Intermittent ClaudicationSUNFITNCT02341716
Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication
A study testing WA, SET and HET in people with Intermittent Claudication, run by Lennart Jivegård at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- WA, SET and HET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2014to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Södra Älvsborgs Hospital
Borås, Västra Götaland County, 50182
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41345
About this study
Official title: Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
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).
Read the 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.
- Conditions
- Intermittent Claudication
- Being tested
- WA, SET, HET
- Keywords
- intermittent claudication, exercise therapy, physiotherapy
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAProcedure or surgery
Walk advice with Nordic Poles and best medical treatment
SETProcedure or surgery
Walk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy
HETProcedure or surgery
Walk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Walk advice | Active comparator | 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. Receives: Procedure: WA |
| Hospital-based supervised exercise | Active comparator | 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. Receives: Procedure: SET |
| Home-based supervised exercise | Active comparator | 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. Receives: Procedure: HET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 months, change
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Measured: Baseline and 12 months, change
Secondary outcomes (28)
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Measured: Baseline and 12 months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Measured: Baseline and 12 months, change
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
Measured: Baseline and 12 months, change
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)
Measured: 12 months
HbA1c and serum lipids
Standard blood tests
Measured: Baseline and 12 months, change
Ankle-brachial-index (ABI)
The highest pressure at the ipsilateral ankle level divided by the simultaneously measured arm blood pressure
Measured: Baseline and 12 months, change
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
Measured: 12 months
Cardiovascular events
Cardiovascular adverse events, minor and major, during the course of the study
Measured: 12 months
Muscular-skeletal events
Muscular-skeletal events, minor and major, during the course of the study
Measured: 12 months
Vascular surgical revascularization
Invasive vascular procedure in the lower limb(s) during the course of the study
Measured: 12 months
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
Measured: Baseline and three months, change
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
Measured: Baseline and six months, change
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
Measured: Six and 12 months, change
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Measured: Baseline and three months, change
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Measured: Baseline and six months, change
Generic health-related quality of life (SF36)
Short-form 36 is an extensively used and validated generic health-related quality of life instrument
Measured: Six and 12 months, change
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Measured: Baseline and three months, change
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Measured: Baseline and six months, change
Disease-specific health-related quality of life (VascuQoL)
VascuQoL is a frequently used disease-specific (PAD) HRQoL instrument, validated in Swedish.
Measured: Six and 12 months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Measured: Baseline and three months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Measured: Baseline and six months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
The WIQ questionnaire is a frequently used questionnaire to quantify walking impairment and is validated in Swedish
Measured: Six and 12 months, change
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
Measured: Baseline and three months, change
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
Measured: Baseline and six months, change
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
Measured: Six and 12 months, change
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)
Measured: Three months
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)
Measured: Six months
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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2021
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lennart Jivegård
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor-investigator, Lennart Jivegård, Sahlgrenska University Hospital
- Investigators
- Lennart Jivegård, MD, Lecturer, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341716
- Sponsor's protocol ID
- SahlgrenskaUH
- Acronym
- SUNFIT
- Status last verified
- May 2022
- First submitted
- 12 Jan 2015
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandberg A, Back M, Cider A, Jivegard L, Sigvant B, Nordanstig J. Impact of walk advice alone or in combination with supervised or home-based structured exercise on patient-reported physical function and generic and disease-specific health related quality of life in patients with intermittent claudication, a secondary analysis in a randomized clinical trial. Health Qual Life Outcomes. 2023 Oct 23;21(1):114. doi: 10.1186/s12955-023-02198-8.
PubMed 37872617Sandberg A, Nordanstig J, Cider A, Jivegard L, Hagstromer M, Back M. The Impact of Nordic Pole Walk Advice Alone or in Combination With Exercise Strategies on Daily Physical Activity in Patients With Intermittent Claudication: A Randomized Clinical Trial. Phys Ther. 2023 Nov 4;103(11):pzad086. doi: 10.1093/ptj/pzad086.
PubMed 37459237Sandberg A, Back M, Cider A, Jivegard L, Sigvant B, Wittboldt S, Nordanstig J. Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial. Eur J Cardiovasc Nurs. 2023 May 25;22(4):400-411. doi: 10.1093/eurjcn/zvac070.
PubMed 35917174Sandberg 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.
PubMed 31147129
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT02341716
- Acronym / sponsor ID
- SUNFIT / SahlgrenskaUH
- Conditions
- Intermittent Claudication
- Keywords
- intermittent claudication, exercise therapy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Lennart JivegårdUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walk advice | Active comparator | Procedure: WAAll 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. |
| Hospital-based supervised exercise | Active comparator | Procedure: SETAll 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. |
| Home-based supervised exercise | Active comparator | Procedure: HETAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAWalk advice with Nordic Poles and best medical treatment | Procedure or surgery | Walk advice |
| SETWalk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy | Procedure or surgery | Hospital-based supervised exercise |
| HETWalk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy | Procedure or surgery | Home-based supervised exercise |
Primary outcome
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
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
28 secondary outcomes
Disease-specific health-related quality of life (VascuQoL)
Time frame: Baseline and 12 months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
Time frame: Baseline and 12 months, change
Physical activity
Time frame: Baseline and 12 months, change
Compliance to exercise therapy
Time frame: 12 months
HbA1c and serum lipids
Time frame: Baseline and 12 months, change
Ankle-brachial-index (ABI)
Time frame: Baseline and 12 months, change
Patient-specified goals with treatment (PSFS)
Time frame: 12 months
Cardiovascular events
Time frame: 12 months
Muscular-skeletal events
Time frame: 12 months
Vascular surgical revascularization
Time frame: 12 months
Six-minutes-walk-test walking distance (6MWD)
Time frame: Baseline and three months, change
Six-minutes-walk-test walking distance (6MWD)
Time frame: Baseline and six months, change
Six-minutes-walk-test walking distance (6MWD)
Time frame: Six and 12 months, change
Generic health-related quality of life (SF36)
Time frame: Baseline and three months, change
Generic health-related quality of life (SF36)
Time frame: Baseline and six months, change
Generic health-related quality of life (SF36)
Time frame: Six and 12 months, change
Disease-specific health-related quality of life (VascuQoL)
Time frame: Baseline and three months, change
Disease-specific health-related quality of life (VascuQoL)
Time frame: Baseline and six months, change
Disease-specific health-related quality of life (VascuQoL)
Time frame: Six and 12 months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
Time frame: Baseline and three months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
Time frame: Baseline and six months, change
Walking impairment (Walking Impairment Questionnaire, WIQ)
Time frame: Six and 12 months, change
Physical activity
Time frame: Baseline and three months, change
Physical activity
Time frame: Baseline and six months, change
Physical activity
Time frame: Six and 12 months, change
Compliance to exercise therapy
Time frame: Three months
Compliance to exercise therapy
Time frame: Six months
Patient-specified goals with treatment (PSFS)
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 37872617Sandberg A, Back M, Cider A, Jivegard L, Sigvant B, Nordanstig J. Impact of walk advice alone or in combination with supervised or home-based structured exercise on patient-reported physical function and generic and disease-specific health related quality of life in patients with intermittent claudication, a secondary analysis in a randomized clinical trial. Health Qual Life Outcomes. 2023 Oct 23;21(1):114. doi: 10.1186/s12955-023-02198-8.
- Derived from this study: PubMed 37459237Sandberg A, Nordanstig J, Cider A, Jivegard L, Hagstromer M, Back M. The Impact of Nordic Pole Walk Advice Alone or in Combination With Exercise Strategies on Daily Physical Activity in Patients With Intermittent Claudication: A Randomized Clinical Trial. Phys Ther. 2023 Nov 4;103(11):pzad086. doi: 10.1093/ptj/pzad086.
- Derived from this study: PubMed 35917174Sandberg A, Back M, Cider A, Jivegard L, Sigvant B, Wittboldt S, Nordanstig J. Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial. Eur J Cardiovasc Nurs. 2023 May 25;22(4):400-411. doi: 10.1093/eurjcn/zvac070.
- Derived from this study: PubMed 31147129Sandberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lennart Jivegård, MD, Lecturer principal investigator
Sahlgrenska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WA, SET and HET in people with Intermittent Claudication, run by Lennart Jivegård at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minutes-walk-test walking distance (6MWD) (time frame: Baseline and 12 months, change). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341716, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.