Abstract
Background: Treatment for locally advanced oesophagogastric adenocarcinoma involves neoadjuvant chemotherapy which has a negative impact on patient fitness. Using ‘prehabilitation’ to increase activity levels and fitness may affect physiology, post-operative outcomes and improve patient wellbeing and quality of life. The aims of the trial were to address the feasibility and acceptability of recruiting participants to a home-based prehabilitation programme and provide data to allow design of future studies.
Methods: We recruited patients to a single-arm feasibility trial of home-based exercise prehabilitation. Eligible patients were aged ≥18yrs, had operable oesophageal or gastric adenocarcinoma, and were receiving neoadjuvant chemotherapy at our tertiary referral hospital. All participants commenced a home-based exercise programme utilising pedometers and step counting to target daily aerobic exercise sessions alongside daily strengthening exercises. A weekly telephone consultation directed the exercise programme and facilitated weekly data collection. The primary (feasibility) outcomes for the trial were a) recruitment rate, b) completion rate, c) engagement with the programme (use of pedometers, recording step counts, telephone consultations), d) compliance with exercise sessions, exercise intensity and strengthening exercises.
Results: There were 42 patients recruited, the recruitment rate was 72.4% (42/58). 92.3% (36/39) of patients completed the exercise programme. There was 98.7% (IQR 93.2-100.0%) compliance with wearing a pedometer and recording data, and 100.0% (IQR 93.1- 100.0%) compliance with a weekly telephone consultation. Exercise sessions and strengthening exercises were completed 70.2% (IQR 53.1-88.9%) and 69.4% (IQR 52.1-84.3%) of the time, respectively. Appropriate exercise intensity was recorded 96% (IQR 85.4-99.4%) of the time. There were no adverse events. Participants were enrolled in the exercise programme for a median of 91 days (IQR 84 to 105 days).
Conclusions: The results of this trial support the feasibility and acceptability of recruiting participants to an appropriately powered randomised controlled trial of prehabilitation.
Trial registration: Clinicaltrials.gov NCT04194463. Registered 11th December 2019 – retrospectively registered, https:// clinicaltrials.gov/ct2/show/NCT04194463
Methods: We recruited patients to a single-arm feasibility trial of home-based exercise prehabilitation. Eligible patients were aged ≥18yrs, had operable oesophageal or gastric adenocarcinoma, and were receiving neoadjuvant chemotherapy at our tertiary referral hospital. All participants commenced a home-based exercise programme utilising pedometers and step counting to target daily aerobic exercise sessions alongside daily strengthening exercises. A weekly telephone consultation directed the exercise programme and facilitated weekly data collection. The primary (feasibility) outcomes for the trial were a) recruitment rate, b) completion rate, c) engagement with the programme (use of pedometers, recording step counts, telephone consultations), d) compliance with exercise sessions, exercise intensity and strengthening exercises.
Results: There were 42 patients recruited, the recruitment rate was 72.4% (42/58). 92.3% (36/39) of patients completed the exercise programme. There was 98.7% (IQR 93.2-100.0%) compliance with wearing a pedometer and recording data, and 100.0% (IQR 93.1- 100.0%) compliance with a weekly telephone consultation. Exercise sessions and strengthening exercises were completed 70.2% (IQR 53.1-88.9%) and 69.4% (IQR 52.1-84.3%) of the time, respectively. Appropriate exercise intensity was recorded 96% (IQR 85.4-99.4%) of the time. There were no adverse events. Participants were enrolled in the exercise programme for a median of 91 days (IQR 84 to 105 days).
Conclusions: The results of this trial support the feasibility and acceptability of recruiting participants to an appropriately powered randomised controlled trial of prehabilitation.
Trial registration: Clinicaltrials.gov NCT04194463. Registered 11th December 2019 – retrospectively registered, https:// clinicaltrials.gov/ct2/show/NCT04194463
Original language | English |
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Article number | 173 |
Journal | Pilot and Feasibility Studies |
DOIs | |
Publication status | Published - 9 Aug 2022 |