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Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training for Intermittent Claudication
Led by Norwegian University of Science and Technology · Updated on 2025-06-06
100
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Norwegian University of Science and Technology
Lead Sponsor
S
Sykehuset i Vestfold HF
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a home-based exercise program called "five plus training" improves walking ability better than the current recommendation of walking for at least 30 minutes three times per week in patients with intermittent claudication. This condition causes pain in the calves due to poor blood flow during walking, and the study aims to determine which exercise method enhances walking distance and quality of life. The trial is sponsored by the Norwegian University of Science and Technology and includes randomized, double-blind assignment to exercise groups. Participants are randomly assigned to either the "five plus training" group or a walking group. The "five plus training" involves standing in front of a wall for balance support and repeatedly lifting the body onto tiptoes with the calf muscles until pain starts, then performing five additional calf raises to promote muscle blood flow. The walking group is instructed to walk for at least 30 minutes three times weekly. This training continues over a 12-week period to compare effects. During the study, participants' walking distance is measured using a treadmill test, and their quality of life is assessed through questionnaires. The ankle-brachial index, a test comparing blood pressure at the ankle and arm, is also monitored. These assessments help evaluate changes in walking capability and symptoms. The study follows participants for 12 weeks, with ongoing monitoring to assess the safety and impact of the exercise programs.
CONDITIONS
Brief Title
Exercise Training Study of Patients With Claudicatio Intermittens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pain in the calves after walking 300 meters or less measured on a treadmill
- Stable symptoms for 6 months or more
- Pain disappears within 5 minutes after stopping walking
- Ankle-Brachial index of 0.7 or lower at rest
- Using statins and antiplatelet drugs for at least 3 months
- Age 18 years or older
- Signed informed consent
You will not qualify if you...
- Pain in hips or areas outside the calves while walking
- Pain lasting more than 5 minutes after stopping walking
- Unable to compress arteries when measuring ankle-brachial index or index lower than 0.4
- Using statins and antiplatelet drugs for less than 3 months
- Symptoms lasting less than 6 months
- Diabetes with HbA1c over 48 mmol/mol (6%)
- Revascularization procedure in the last 6 months
- Pain in calves after walking longer than 300 meters
- Reduced ankle mobility
- Reduced physical ability to perform treadmill test
- Age under 18 years
- General conditions impairing ability to participate, including obesity, chronic obstructive pulmonary disease, heart disease, arthrosis, inflammatory joint diseases
- No signed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants perform either the "five plus training" or walking at least 30 minutes three times per week as part of the exercise training program.
Regular monitoring visits during the 12 weeks
Trial Site Locations
Total: 14 locations
1
Ålesund Sykehus
Ålesund, Norway
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2
Haukeland University Hospital
Bergen, Norway
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3
Vestre Viken, Drammen sykehus
Drammen, Norway
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4
Sykehuset Østfold Kalnes
Grålum, Norway
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5
Sykehuset Innlandet HF
Hamar, Norway
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6
Sørlandet Sykehus HF Kristiansand
Kristiansand, Norway
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7
Ahus University Hospital
Oslo, Norway
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8
Oslo university Hospital
Oslo, Norway
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9
Stavanger University Hospital
Stavanger, Norway
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10
St Olavs University Hospital
Trondheim, Norway
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11
Sykehuset i Vestfold HF
Tønsberg, Norway
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12
Sahlgrenska University Hospital
Gothenburg, Sweden
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13
Linköping University Hiospital
Linköping, Sweden
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14
Karolinska Institute
Stockholm, Sweden
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Research Team
E
Erney Mattsson, Professor
J
Joakim Nordanstig, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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