Exercise Training Study of Patients With Claudicatio Intermittens

NCT ID: NCT06448390

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. During the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect.

The patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and Ankle-brachial index.

Conditions

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Claudication, Intermittent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

web-based prospective randomization between two groups of training for patients with Claudicatio intermittens
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The care provider instructs about the training version. Other people will evaluate the participants before and after the training period

Study Groups

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Five plus training

During "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect.

Group Type ACTIVE_COMPARATOR

Physical training

Intervention Type BEHAVIORAL

The patients are randomized to either walking 30 minutes 3 times a week or lifting the body to a tip toe position three times a day until pain in the claves and then add another five liftings before ending the session

walking

Walking at least 30 minutes three times per week.

Group Type ACTIVE_COMPARATOR

Physical training

Intervention Type BEHAVIORAL

The patients are randomized to either walking 30 minutes 3 times a week or lifting the body to a tip toe position three times a day until pain in the claves and then add another five liftings before ending the session

Interventions

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Physical training

The patients are randomized to either walking 30 minutes 3 times a week or lifting the body to a tip toe position three times a day until pain in the claves and then add another five liftings before ending the session

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Pain in the calves after 300 m, or less measured on a treadmill
2. Stable symptoms last 6 months or more
3. The pain must be gone within 5 minutes after the patients stop walking
4. Ankle-Brachial index at 0.7 or lower at rest
5. Using statins and antiplatelet drugs since at least 3 months
6. age\> 18 years
7. Signed consent

Exclusion Criteria

1. pain in the hips or elsewhere outside the calves while walking
2. Remaining pain more than 5 minutes after stopped walking.
3. Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
4. Use of statins and antiplatelet drugs less than 3 months
5. symptoms less than 6 months
6. Diabetes measured with HbA1c being over 48 mmol/mol (6%)
7. Revascularisation the last 6 months
8. Pain in the calves after longer than 300 m measured on a treadmill
9. Reduced mobility in the ankles
10. Reduced physical ability to perform a test on a treadmill.
11. Age less than 18 years
12. General conditions that impairs the ability to take part in a training study including Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .
13. No Signed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset i Vestfold HF

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Sykehuset Ostfold

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Drammen sykehus

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joakim Nordanstig, Professor

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Ålesund Sykehus

Ålesund, , Norway

Site Status RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Vestre Viken, Drammen sykehus

Drammen, , Norway

Site Status RECRUITING

Sykehuset Østfold Kalnes

Grålum, , Norway

Site Status RECRUITING

Sykehuset Innlandet HF

Hamar, , Norway

Site Status RECRUITING

Sørlandet Sykehus HF Kristiansand

Kristiansand, , Norway

Site Status RECRUITING

Ahus University Hospital

Oslo, , Norway

Site Status RECRUITING

Oslo university Hospital

Oslo, , Norway

Site Status RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status RECRUITING

St Olavs University Hospital

Trondheim, , Norway

Site Status RECRUITING

Sykehuset i Vestfold HF

Tønsberg, , Norway

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Linköping University Hiospital

Linköping, , Sweden

Site Status RECRUITING

Karolinska Institute

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Norway Sweden

Central Contacts

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Erney Mattsson, Professor

Role: CONTACT

0046737854490

Joakim Nordanstig, Professor

Role: CONTACT

+46708259496

Facility Contacts

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Torstein Fjørtoft, MD

Role: primary

Antje Butter, MD

Role: primary

+4740537892

Antje Butter

Role: backup

Øyvind Werpen Skoe, MD

Role: primary

Thore Borgenvik, MD

Role: primary

Thomas Spansdahl, MD

Role: primary

Erik Mulder Pettersen, MD

Role: primary

Jon Tryggve Ask-Nessa, MD

Role: primary

MD

Role: backup

Toril Rabben, MD

Role: primary

Joar Reutz Nøttveit, MD

Role: primary

Magne Torsteinsen, MD

Role: primary

Torbjørn Bakken, MD

Role: primary

+4733 34 20 00

Joakim Nordanstig, MD

Role: primary

Håkan Persson, MD

Role: primary

Sofie Aronsson, MD

Role: backup

Rebecka Hultgren

Role: primary

Other Identifiers

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4/2024

Identifier Type: -

Identifier Source: org_study_id

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