Exercise Training Study of Patients With Claudicatio Intermittens

NCT06448390 | Recruiting DMC

• 1 other identifier: 4/2024
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 14

Brief Summary

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.

Conditions

Claudication, Intermittent

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Five plus training

ACTIVE COMPARATOR

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

walking

ACTIVE COMPARATOR

Walking at least 30 minutes three times per week.

Behavioral: Physical training

Interventions

Physical training 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

Five plus training; walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Sykehuset i Vestfold HF: collaborator
• Oslo University Hospital: collaborator
• Haukeland University Hospital: collaborator
• Sorlandet Hospital HF: collaborator
• St. Olavs Hospital: collaborator
• Sykehuset Ostfold: collaborator
• Helse Stavanger HF: collaborator
• Sykehuset Innlandet HF: collaborator
• Drammen sykehus: collaborator
• Alesund Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Karolinska Institutet: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (14)

Ålesund Sykehus

Ålesund, Norway

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Vestre Viken, Drammen sykehus

Drammen, Norway

RECRUITING

Sykehuset Østfold Kalnes

Grålum, Norway

RECRUITING

Sykehuset Innlandet HF

Hamar, Norway

RECRUITING

Sørlandet Sykehus HF Kristiansand

Kristiansand, Norway

RECRUITING

Ahus University Hospital

Oslo, Norway

RECRUITING

Oslo university Hospital

Oslo, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

St Olavs University Hospital

Trondheim, Norway

RECRUITING

Sykehuset i Vestfold HF

Tønsberg, Norway

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Linköping University Hiospital

Linköping, Sweden

RECRUITING

Karolinska Institute

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joakim Nordanstig, Professor

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erney Mattsson, Professor

CONTACT

0046737854490; erney.mattsson@gmail.com

Joakim Nordanstig, Professor

CONTACT

+46708259496; joakim.nordanstig@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The care provider instructs about the training version. Other people will evaluate the participants before and after the training period
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: web-based prospective randomization between two groups of training for patients with Claudicatio intermittens

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (11); SE (3)