Exercise Training Study of Patients With Claudicatio Intermittens

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

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.

Study Overview

• Status: Recruiting
• Conditions: Claudication, Intermittent
• Intervention / Treatment: Behavioral: Physical training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erney Mattsson, Professor; Phone Number: 0046737854490; Email: erney.mattsson@gmail.com
• Study Contact Backup: Name: Joakim Nordanstig, Professor; Phone Number: +46708259496; Email: joakim.nordanstig@vgregion.se

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Antje Butter, MD; Phone Number: +4740537892; Email: antje.butter@helse-bergen.no
    • Contact: Antje Butter; Email: antje.butter@helse-bergen.no
  • Drammen, Norway
    • Recruiting
    • Vestre Viken, Drammen sykehus
    • Contact: Øyvind Werpen Skoe, MD; Email: Oyvind.skoe@gmail.com
    • Sub-Investigator: Silje Thronæs
  • Grålum, Norway
    • Recruiting
    • Sykehuset Østfold Kalnes
    • Contact: Thore Borgenvik, MD; Email: Thore.Langfeldt.Borgenvik@so-hf.no
  • Hamar, Norway
    • Recruiting
    • Sykehuset Innlandet HF
    • Contact: Thomas Spansdahl, MD; Email: thomas.spansdahl@sykehuset-innlandet.no
  • Kristiansand, Norway
    • Recruiting
    • Sørlandet sykehus HF Kristiansand
    • Contact: Erik Mulder Pettersen, MD; Email: Erik.Mulder.Pettersen@sshf.no
    • Sub-Investigator: Marie Tryland Høiberg, nurse
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Toril Rabben, MD; Email: torabb@ous-hf.no
  • Oslo, Norway
    • Recruiting
    • Ahus University Hospital
    • Contact: MD
    • Contact: Jon Tryggve Ask-Nessa, MD; Email: Jon.Tryggve.Ask-Nessa@ahus.no
    • Sub-Investigator: Anne Rigmor Holten, nurse
    • Sub-Investigator: Helene Nådland, Physiotherap
  • Stavanger, Norway
    • Recruiting
    • Stavanger University Hospital
    • Contact: Joar Reutz Nøttveit, MD; Email: jorz@sus.no
    • Sub-Investigator: Tore Galdal
  • Trondheim, Norway
    • Recruiting
    • St Olavs University Hospital
    • Contact: Magne Torsteinsen, MD; Email: Magne.Torsteinsen@stolav.no
    • Sub-Investigator: Cathrine Kjemperud, nurse
  • Tønsberg, Norway
    • Recruiting
    • Sykehuset I Vestfold HF
    • Contact: Torbjørn Bakken, MD; Phone Number: +4733 34 20 00; Email: torbjorn.bakken@siv.no
    • Principal Investigator: Torbjørn Bakken, MD
    • Sub-Investigator: Hege Eriksen, Nurse
  • Ålesund, Norway
    • Recruiting
    • Ålesund sykehus
    • Contact: Torstein Fjørtoft, MD; Email: Torstein.fj@gmail.com
• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Joakim Nordanstig, MD; Email: joakim.nordanstig@vgregion.se
    • Sub-Investigator: Monica Broeren, nurse
    • Sub-Investigator: Wiveka Björkvall, nurse
  • Linköping, Sweden
    • Recruiting
    • Linköping University Hiospital
    • Contact: Håkan Persson, MD; Email: hakan.parsson@liu.se
    • Contact: Sofie Aronsson, MD; Email: Sofie.Aronsson@regionostergotland.se
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institute
    • Contact: Rebecka Hultgren; Email: rebecka.hultgren@ki.se
    • Sub-Investigator: Olga Nilsson, Nurse
    • Sub-Investigator: Alicia Garcia Lantz, Nurse
    • Sub-Investigator: Alessia Quaranta, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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
Active Comparator: walking; Walking at least 30 minutes three times per week.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
walking distance	Measured on a tread mill before and after the training period	12 weeks
Quality of life	Measured with a questionnaire (VASCUQOL-6) before and after the training period	12 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Karolinska Institutet; Oslo University Hospital; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF; St. Olavs Hospital; Sykehuset Innlandet HF; Alesund Hospital; University Hospital, Linkoeping; Sykehuset Ostfold; Drammen sykehus; Sykehuset i Vestfold HF; Sahlgrenska University Hospital
• Investigators: Principal Investigator: Joakim Nordanstig, Professor, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 4/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the ethical permission no individual data can be shared or identified. The participant can be fully informed if that is requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No