Clinical trial NCT01776710: Structured EDucation for Rehabilitation in Intermittent Claudication
Official title: Development and Piloting of a Pragmatic Structured Education Programme That Promotes Walking in Patients With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Intermittent claudication
Behavior therapy
Walking
Exercise
Patient education
Randomized controlled trial
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
name: University of York
name: University of Stirling
First posted: 2013-01-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost physical function through exercise rehabilitation. Supervised exercise programmes can markedly improve walking capacity, but these are resource intensive, National Health Service provision is limited, and patients cite accessing services as a barrier to participation.

Increasing walking activity via a structured education programme might be a pragmatic solution for improving walking capacity, health and wellbeing in patients with IC; however, further research is needed to substantiate this. Hence, the aim of this project is to develop a pragmatic education programme to increase walking in these patients and to collect data on its feasibility to inform the development of a definitive trial investigating clinical and cost effectiveness.

Focus groups will be conducted to inform the development of the education programme. Programme components will be theoretically-underpinned and evidence-based. The development of the programme will be an iterative process involving pilot work, feedback, evaluation, and revision. The programme will then be assessed in a randomised controlled pilot study with 6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain preliminary data of its impact on important outcomes (daily steps/physical activity, walking capacity, quality of life, illness perceptions).


Eligibility criteria: Inclusion Criteria:

* Men and women aged \>18 years with intermittent claudication due to peripheral arterial disease
* Stable disease for \>3 months
* Able to provide consent
* Able to read and speak English to a level allowing satisfactory completion of written questionnaires and to participate in the education intervention

Exclusion Criteria:

* Previous endovascular/surgical interventions
* Scheduled endovascular/surgical intervention
* Critical limb ischaemia
* Those whose function is uniquely impaired, e.g. wheelchair-bound patients and patients with lower-extremity amputation(s)
* Presence of contraindications to exercise or co-morbidities that limit exercise performance to a greater extent than the intermittent claudication (e.g. severe arthritis)
* Major surgery, myocardial infarction or stroke/transient ischemic attack in the previous 6 months
* Patients who already perform greater than 30 min of structured exercise three times weekly (self-reported)

Primary outcomes:
measure: Feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: Daily steps and physical activity
timeFrame: 6 weeks
measure: Claudication onset and maximum walking distances
timeFrame: 6 weeks
measure: Self-reported ambulatory ability
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Psychological constructs representing the key mediators of behaviour change
timeFrame: 6 weeks
Other outcomes:
measure: Participants' experiences
timeFrame: 6 weeks
Locations:
city: York
country: United Kingdom
facility: Department of Health Sciences, University of York
state: North Yorkshire
Study officials:
affiliation: University of York
name: Garry A Tew, PhD
role: PRINCIPAL_INVESTIGATOR
References: