NCT02341716

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

6.5 years

First QC Date

January 12, 2015

Last Update Submit

May 5, 2022

Conditions

Intermittent Claudication

Keywords

intermittent claudicationexercise therapyphysiotherapy

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Baseline and 12 months, change

Secondary Outcomes (28)

  • Disease-specific health-related quality of life (VascuQoL)

    Baseline and 12 months, change

  • Walking impairment (Walking Impairment Questionnaire, WIQ)

    Baseline and 12 months, change

  • Physical activity

    Baseline and 12 months, change

  • Compliance to exercise therapy

    12 months

  • HbA1c and serum lipids

    Baseline and 12 months, change

  • +23 more secondary outcomes

Study Arms (3)

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.

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.

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.

Procedure: HET

Interventions

WAPROCEDURE

Walk advice with Nordic Poles and best medical treatment

Walk advice
SETPROCEDURE

Walk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy

Hospital-based supervised exercise
HETPROCEDURE

Walk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy

Home-based supervised exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Södra Älvsborgs Hospital

Borås, Västra Götaland County, 50182, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 37872617DERIVED

  • Sandberg 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.

    PMID: 37459237DERIVED

  • Sandberg 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.

    PMID: 35917174DERIVED

  • 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.

    PMID: 31147129DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lennart Jivegård, MD, Lecturer

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, University lecturer

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

September 1, 2014

Primary Completion

March 1, 2021

Study Completion

June 1, 2022

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

SE(2)