A Clinical Trial on the Effects of Home-based Five Plus Exercise Training

Norwegian University of Science and Technology

Status: Completed

Conditions: Intermittent Claudication

Treatments: Other: Five plus exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02310256

2011/2533/REK midt

Details and patient eligibility

About

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.

Enrollment: 30 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with intermittent claudication secondary to vascular insufficiency
• An ankle-brachial index between 0.4 and 0.9.

Exclusion criteria

• Diagnosed with critical limb ischemia
• Ankle-brachial index (ABI) > 0.90 or < 0.4
• Limited exercise tolerance
• Warfarin or heparin usage
• Underwent a vascular intervention in the last 6 months
• Active cancer, renal- or liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Usual care

No Intervention group

Five Plus

Active Comparator group

Description:

Exercise training

Treatment:

Other: Five plus exercise training