Structured EDucation for Rehabilitation in Intermittent Claudication

NCT01776710 | Completed

• 1 other identifier: STH17173
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Keywords

Intermittent claudication; Behavior therapy; Walking; Exercise; Patient education; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Feasibility

  The feasibility of the structured education programme will be assessed in terms of recruitment, retention, compliance and acceptability, the latter of which will assessed via participant interviews.

  6 weeks

Secondary Outcomes (5)

• Daily steps and physical activity

  6 weeks

• Claudication onset and maximum walking distances

  6 weeks

• Self-reported ambulatory ability

  6 weeks

• Health-related quality of life

  6 weeks

• Psychological constructs representing the key mediators of behaviour change

  6 weeks

Other Outcomes (1)

• Participants' experiences

  6 weeks

Study Arms (2)

Structured education

EXPERIMENTAL

The structured education intervention will comprise a 3-hour education workshop delivered by two trained facilitators and a follow-up telephone call 2 weeks later. The aims of the education programme are to enhance patients' understanding of peripheral arterial disease and intermittent claudication, and to support patients in increasing their daily walking activity. Key behaviour change techniques that will be incorporated will include goal setting, action planning, barrier identification/problem solving, prompt review of behavioural goals, prompt self-monitoring of behaviour, and instructions on how to perform the behaviour.

Behavioral: Structured education

Standard care control

NO INTERVENTION

Standard care will consist of general advice to increase walking and an information sheet on peripheral arterial disease, plus a consultation with a Consultant Vascular Surgeon.

Interventions

Structured education BEHAVIORAL

The structured education intervention will comprise a 3-hour education workshop delivered by two trained facilitators and a follow-up telephone call 2 weeks later. The aims of the education programme are to enhance patients' understanding of peripheral arterial disease and intermittent claudication, and to support patients in increasing their daily walking activity. Key behaviour change techniques that will be incorporated will include goal setting, action planning, barrier identification/problem solving, prompt review of behavioural goals, prompt self-monitoring of behaviour, and instructions on how to perform the behaviour.

Structured education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator
• University of York: collaborator
• University of Stirling: collaborator

Study Sites (1)

Department of Health Sciences, University of York

York, North Yorkshire, YO105DD, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Garry A Tew, PhD

  University of York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

GB (1)