TY - JOUR
T1 - Evaluating the feasibility and acceptability of an exercise and behaviour change intervention in socioeconomically deprived patients with peripheral arterial disease
T2 - The textpad study protocol
AU - Cucato, Gabriel
AU - Snowden, Chris
AU - McCone, Emma
AU - Nesbitt, Craig
AU - Nandhra, Sandip
AU - Fong, Mackenzie
AU - Kane, Eileen
AU - Rowland, Maisie
AU - Bhattarai, Nawaraj
AU - Court, Paul
AU - Bell, Oliver
AU - Saxton, John Michael
AU - Prentis, James
N1 - Funding information: Funded by the League of Friends of Freeman Hospital and departmental funds. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
PY - 2022/6/24
Y1 - 2022/6/24
N2 - This pilot randomised controlled trial aims to assess the feasibility and acceptability of a 12-week home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with peripheral artery disease (PAD). The study will also determine the preliminary effectiveness of the intervention for improving clinical and health outcomes. Sixty patients with PAD who meet the inclusion criteria will be recruited from outpatient clinic at the Freeman Hospital, United Kingdom. The intervention group will undergo telehealth behaviour intervention performed 3 times per week over 3 months. This program will comprise a home-based exercise (twice a week) and an individual lifestyle program (once per week). The control group will receive general health recommendations and advice to perform unsupervised walking training. The primary outcome will be feasibility and acceptability outcomes. The secondary outcomes will be objective and subjective function capacity, quality of life, dietary quality, physical activity levels, sleep pattern, alcohol and tobacco use, mental wellbeing, and patients’ activation. This pilot study will provide preliminary evidence of the feasibility, acceptability and effectiveness of home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with PAD. In addition, the variance of the key health outcomes of this pilot study will be used to inform the sample size calculation for a future fully powered, multicentre randomized clinical trial.
AB - This pilot randomised controlled trial aims to assess the feasibility and acceptability of a 12-week home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with peripheral artery disease (PAD). The study will also determine the preliminary effectiveness of the intervention for improving clinical and health outcomes. Sixty patients with PAD who meet the inclusion criteria will be recruited from outpatient clinic at the Freeman Hospital, United Kingdom. The intervention group will undergo telehealth behaviour intervention performed 3 times per week over 3 months. This program will comprise a home-based exercise (twice a week) and an individual lifestyle program (once per week). The control group will receive general health recommendations and advice to perform unsupervised walking training. The primary outcome will be feasibility and acceptability outcomes. The secondary outcomes will be objective and subjective function capacity, quality of life, dietary quality, physical activity levels, sleep pattern, alcohol and tobacco use, mental wellbeing, and patients’ activation. This pilot study will provide preliminary evidence of the feasibility, acceptability and effectiveness of home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with PAD. In addition, the variance of the key health outcomes of this pilot study will be used to inform the sample size calculation for a future fully powered, multicentre randomized clinical trial.
KW - Exercise
KW - Feasibility Studies
KW - Humans
KW - Peripheral Arterial Disease/therapy
KW - Pilot Projects
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
UR - http://www.scopus.com/inward/record.url?scp=85132821460&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0269999
DO - 10.1371/journal.pone.0269999
M3 - Article
C2 - 35749440
SN - 1932-6203
VL - 17
JO - PLoS One
JF - PLoS One
IS - 6
M1 - e0269999
ER -
