Cross-sectoral Rehabilitation for Patients With Intermittent Claudication

NCT03730623 | Unknown DMC

• 1 other identifier: H-17004183
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise training combined with other lifestyle changes are essential elements in conservative management of patients with Intermittent Claudication (IC). IC is essentially caused by atherosclerosis, which reduces blood flow to the legs and leads to cramping leg pain when walking. Patients suffering from IC may have difficulty in exercising and changing lifestyle without systematic intervention despite the risk of morbidity, mortality and hospitalization. Today, rehabilitation programs, including supervised exercise, exist for patients suffering ischemic heart disease but not for patients with IC, despite evidence that exercise therapy is highly beneficial for patients suffering IC. The overall aim of the present study is to examine the effect of conservative management of patients with IC provided as a three month, cross-sectoral exercise and lifestyle intervention program based on the already established cardiac rehabilitation program. Outcome will be assessed on walking distance and secondly on lifestyle changes and patient reported outcomes. Implications: The project will provide evidence for the effect of cross-sectoral collaborative conservative management of patients with IC, using the existing rehabilitation program already offered to patients suffering ischemic heart disease. Moreover, it will elicit knowledge on patient perceptions of conservative management of IC provided as a proactive cross-sectoral intervention and ways to support patients with IC in adhering to conservative management.

Conditions

Intermittent Claudication

Keywords

Supervised exercise training; community based intervention; Rehabilitation Program; Cross-sectoral intervention; Interdisciplinary; Mixed Methods Research

Outcome Measures

Primary Outcomes (1)

• Maximum Walking Distance on a treadmill

  Change from Baseline Maximum Walking Distance at 12 months. Detect an improvement of 60 meters in Maximum Walking Distance in the intervention group compared to the control group, using the standardized Treadmill Walking Test.

  12 months

Secondary Outcomes (7)

• Pain-free walking distance on a treadmill

  12 months

• Quality of Life Measurement

  12 months

• Depression and anxiety Measurement

  12 months

• Self-management Measurement

  12 months

• smoking cessation Measurement

  12 months

Study Arms (2)

Control group

NO INTERVENTION

Usual care. Conservative management of IC

Intervention

EXPERIMENTAL

Supervised exercise

Behavioral: Supervised exercise training

Interventions

Supervised exercise training BEHAVIORAL

Supervised exercise training as a conservative management of intermittent claudication in a community setting based on cardiac rehabilitation program

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed Intermittent Claudication, referred to dept. of vascular surgery and offered conservative management.
• Citizens in the municipalities of the study.
• Able to understand, read and speak Danish.
• Able to perform physical exercise and informed consent to participate in the trial.

You may not qualify if:

• Patients that needs vascular surgery.
• Co-morbidity that hinder participation and to perform physical exercise.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Dept. of Vascular Surgery, Rigshospitalet, University of Copenhagen.

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Siercke M, Jorgensen LP, Missel M, Thygesen LC, Blach PP, Sillesen H, Berg SK. Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial. Trials. 2020 Jan 21;21(1):105. doi: 10.1186/s13063-019-4032-x.

  PMID: 31964402 DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

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

Study Officials

• Selina Kikkenborg Berg, Professor

  University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial with118 participants. Randomization to Control group/standard care or Intervention group: 12 week exercise supervised by physiotherapist, Nurse+ dietitian, pedometer and exercise log-book, smoking cessation and text-message follow up. 6 and 12 month follow up. Primary and secondary endpoints.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 5, 2018
• Study Start: December 5, 2017
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

DK (1)