Supervised exercise programmes to maximise function in PAD-IC.
Research type
Research Study
Full title
Supervised exercise programmes to maximise function and quality of life for patients with intermittent claudication from peripheral arterial disease: A prospective observational feasibility study.
IRAS ID
226828
Contact name
Natalie Vanicek
Contact email
Sponsor organisation
University of Hull
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This is a prospective observational, feasibility study. The purpose of this study is to determine the feasibility of conducting a novel exercise programme compared to standard exercise practice for patients with peripheral arterial disease with intermittent claudication (PAD-IC). Patients will be given a choice of exercise intervention, which will not only provide valuable information on patient preference in their own disease management, but may also increase recruitment and retention rates.
The specific study objectives are to:
1. Determine recruitment, adherence and retention rates;
2. Explore the acceptability to patients of chosen interventions and identify the most important outcomes to them;
3. Assess patient acceptability of study processes, including consideration of any adverse events;
4. Identify a primary outcome measure(s) and its normal variability to inform future sample size
calculations;
5. Assess feasibility of collecting outcome measures data related to patient function, walking ability, strength, health status and quality of life;
6. Ascertain patient adherence to the exercise intervention.The limitations of the current standard treatment are its lack of specificity and personalisation between participants, thus delivering inconsistent results that are focused on improving level walking capacity, without addressing lower limb strength (Cochrane, 2018). The potential effectiveness of eccentric training has been previously documented, proposing better strength (Reeves et al., 2009) and improving tendon properties (Malliaras et al., 2013).
The project will recruit a group of PAD-IC patients from in and around the Hull and East Yorkshire area from within the NHS. The patients will be given a choice to participate in either exercise group 1) novel eccentric training or 2) conventional exercise (standard treatment) group. We will quantify recruitment and adherence rates and explore patient acceptability via focus group sessions. All participants will complete clinical outcome measures, undergo biomechanical testing pre, and post exercise intervention to evaluate the effectiveness of the respective programmes.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0309
Date of REC Opinion
17 Oct 2018
REC opinion
Further Information Favourable Opinion