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A multicentre, assessor-blinded, randomized controlled trial to investigate the effectiveness of a blended intervention, focused on personal feedback and coaching regarding physical activity and protein intake, after discharge in patients who have undergone elective gastro-intestinal or lung cancer surgery

ABSTRACT: Interventions: The blended intervention consists of a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician. With the app, patients are able to self-monitor their daily protein intake and PA level, have insight in personal goals on protein intake and receive (real-time) feedback. The patients receive an ankle-worn PA monitor (PAM) and corresponding application one week prior to surgery to get familiarized with the application. After discharge, the patients continue the use for 3 months and patients will be monitored and coached by a physiotherapist and dietician during this period. The intervention will be tailored on the patients personal needs and preferences based on a shared decision making process with the patient. The patients will be coached by the physiotherapist and dietician following the principles of Motivational Interviewing. Primary outcome(s): The main study endpoint is postoperative recovery in physical functioning measured with the CAT PROMIS-physical functioning item bank. The most important secondary outcome is objectively measured level of physical activity (average stepping minutes per day). Study Design: Randomized controlled trial, Single blinded (masking used), Active, Parallel

DISEASE(S): Patients With Gastro-intestinal Or Lung Cancer Scheduled For Surgery

PROVIDER: 2444277 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Individuals affected by post-covid condition (PCC) show an increased fatigue and the so-called post-exertion malaise (PEM) that led health professionals to advise against exercise although accumulating evidence indicate the contrary. The goal of this study is to determine the impact of a closely monitored 8-week mixed exercise program on physical capacity, symptoms, fatigue, systemic oxidative stress and plasma proteomic profiles of PCC cases. Methods: Twenty-five women and men with PCC assigned sequentially to exercise (n = 15) and non-exercise (n = 10) groups. Individuals with no PCC served as a control group. The exercise program included cardiovascular and resistance exercises. Physical capacity, physical activity level and the presence of common PCC symptoms were measured before and after the intervention. Fatigue was measured the day following each exercise session. Plasma and PBMC samples were collected at the beginning and end of the training program. Glutathione and deoxyguanosine levels in PBMC and plasma proteomic profiles were evaluated. Results: Bicep Curl (p=0.040) and STS-30 (p=0.043) improved to a greater extent in the exercise group than in the non-exercise group. An interaction effect was also observed for the level of physical activity (p=0.007) with a positive effect of the program on their daily functioning and without any adverse effects on general or post-effort fatigue. Glutathione levels showed marked improvement after exercise. Discernable changes were observed in the plasma proteomics profile with certain proteins involved in inflammatory response (SA100A8) decreasing in the exercise group. Conclusion: Supervised exercise adapted to the level of fatigue and ability is safe and effective in PCC patients in improving their general physical capacity and wellbeing. Systemic molecular markers that accompany physical improvement can be monitored by analyzing plasma proteomics and markers of oxidative stress. Large-scale studies will help identify promising molecular markers to objectively monitor patient improvement.

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