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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication

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 Summary:

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-fi
Sponsor: Lennart Jivegård

Current 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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
• 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
• 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)
• HbA1c and serum lipids [ Time Frame: Baseline and 12 months, change ]
  Standard blood tests
• 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
• 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
• Cardiovascular events [ Time Frame: 12 months ]
  Cardiovascular adverse events, minor and major, during the course of the study
• Muscular-skeletal events [ Time Frame: 12 months ]
  Muscular-skeletal events, minor and major, during the course of the study
• Vascular surgical revascularization [ Time Frame: 12 months ]
  Invasive vascular procedure in the lower limb(s) during the course of the study
• 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
• 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
• 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
• 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
• 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
• 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
• 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.
• 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.
• 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.
• Walking impairment (Walking Impairment Questionnaire, WIQ) [ Time Frame: Baseline and three
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Sahlgrenska University Hospital, Sweden
  

  Dates:
  Date Received: January 12, 2015
  Date Started: September 2014
  Date Completion: December 2018
  Last Updated: October 24, 2016
  Last Verified: October 2016