Cross-sectoral Rehabilitation for Patients With Intermittent Claudication: Effects and Patient Experience - The CIPIC-Rehab Study (Cross-sectoral Intervention for Patients With Intermittent Claudication)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Maximum Walking Distance on a treadmill
Study Overview
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.
Detailed Description
Main study:
Randomized Clinical Trial comparing Cross-sectoral Training Intervention for Patients with Intermittent Claudication with standard care.
Patients will be randomized to the intervention or control group using a computer-generated block randomized allocation scheme.
Sample size:
The expected average base line value of maximal walking distance (MWD) has been set to 120 m and the investigators want to detect a 50% improvement (60 m). There is a wide variance in MWD in this patient group, and consequently the standard deviation (SD) is set at 100 m. With a 5% significance level and 80% power, it will thus be necessary to include 88 patients to detect an improvement of 60 m in MWD in the intervention group at 12-months follow-up, compared to the control group. Owing to the previously mentioned risk of comorbidities, combined with an expected loss to follow-up, a drop-out of 25% must be expected, wherefore the investigators plan is to include 118 patients in total (59 in each group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients that needs vascular surgery.
- •Co-morbidity that hinder participation and to perform physical exercise.
Arms & Interventions
Control group
Usual care. Conservative management of IC
Intervention
Supervised exercise
Intervention: Supervised exercise training (Behavioral)
Outcomes
Primary Outcomes
Maximum Walking Distance on a treadmill
Time Frame: 12 months
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.
Secondary Outcomes
- Daily physical activity Measurement(12 months)
- Diet Registration Measurement(12 months)
- Self-management Measurement(12 months)
- Quality of Life Measurement(12 months)
- Pain-free walking distance on a treadmill(12 months)
- Depression and anxiety Measurement(12 months)
- smoking cessation Measurement(12 months)
Investigators
Maj Siercke Bergstedt
Principal Investigator
Rigshospitalet, Denmark