Clinical trial NCT02341716: Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication
Official title: Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Claudication
Keywords: intermittent claudication
exercise therapy
physiotherapy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2015-01-19
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

1. WA with Nordic Poles (NP) + best medical treatment (BMT), or
2. WA with NP + BMT + SET, or
3. 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.

Eligibility 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

Primary outcomes:
measure: Six-minutes-walk-test walking distance (6MWD)
timeFrame: Baseline and 12 months, change
measure: Generic health-related quality of life (SF36)
timeFrame: Baseline and 12 months, change
Secondary outcomes:
measure: Disease-specific health-related quality of life (VascuQoL)
timeFrame: Baseline and 12 months, change
measure: Walking impairment (Walking Impairment Questionnaire, WIQ)
timeFrame: Baseline and 12 months, change
measure: Physical activity
timeFrame: Baseline and 12 months, change
measure: Compliance to exercise therapy
timeFrame: 12 months
measure: HbA1c and serum lipids
timeFrame: Baseline and 12 months, change
measure: Ankle-brachial-index (ABI)
timeFrame: Baseline and 12 months, change
measure: Patient-specified goals with treatment (PSFS)
timeFrame: 12 months
measure: Cardiovascular events
timeFrame: 12 months
measure: Muscular-skeletal events
timeFrame: 12 months
measure: Vascular surgical revascularization
timeFrame: 12 months
measure: Six-minutes-walk-test walking distance (6MWD)
timeFrame: Baseline and three months, change
measure: Six-minutes-walk-test walking distance (6MWD)
timeFrame: Baseline and six months, change
measure: Six-minutes-walk-test walking distance (6MWD)
timeFrame: Six and 12 months, change
measure: Generic health-related quality of life (SF36)
timeFrame: Baseline and three months, change
measure: Generic health-related quality of life (SF36)
timeFrame: Baseline and six months, change
measure: Generic health-related quality of life (SF36)
timeFrame: Six and 12 months, change
measure: Disease-specific health-related quality of life (VascuQoL)
timeFrame: Baseline and three months, change
measure: Disease-specific health-related quality of life (VascuQoL)
timeFrame: Baseline and six months, change
measure: Disease-specific health-related quality of life (VascuQoL)
timeFrame: Six and 12 months, change
measure: Walking impairment (Walking Impairment Questionnaire, WIQ)
timeFrame: Baseline and three months, change
measure: Walking impairment (Walking Impairment Questionnaire, WIQ)
timeFrame: Baseline and six months, change
measure: Walking impairment (Walking Impairment Questionnaire, WIQ)
timeFrame: Six and 12 months, change
measure: Physical activity
timeFrame: Baseline and three months, change
measure: Physical activity
timeFrame: Baseline and six months, change
measure: Physical activity
timeFrame: Six and 12 months, change
measure: Compliance to exercise therapy
timeFrame: Three months
measure: Compliance to exercise therapy
timeFrame: Six months
measure: Patient-specified goals with treatment (PSFS)
timeFrame: Six months
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborgs Hospital
state: Västra Götaland
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Lennart Jivegård, MD, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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.