Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized controlled trial.
Humans
Resistance Training
/ methods
Pancreatic Neoplasms
/ surgery
Biliary Tract Neoplasms
/ complications
Muscle, Skeletal
/ physiopathology
Liver Neoplasms
/ surgery
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Regional Blood Flow
Treatment Outcome
Quality of Life
Muscle Strength
Time Factors
Preoperative Exercise
Muscular Atrophy
/ prevention & control
Sarcopenia
/ prevention & control
Biliary tract cancer
Blood flow restriction training
Liver cancer
Muscle atrophy
Pancreatic cancer
Prehabilitation
Rehabilitation
Skeletal muscle mass
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
04 Jun 2024
04 Jun 2024
Historique:
received:
12
03
2024
accepted:
28
05
2024
medline:
5
6
2024
pubmed:
5
6
2024
entrez:
4
6
2024
Statut:
epublish
Résumé
Patients diagnosed with pancreatic, biliary tract, and liver cancer often suffer from a progressive loss of muscle mass. Given the considerable functional impairments in these patients, high musculoskeletal weight loads may not be well tolerated by all individuals. The use of blood-flow restricted resistance training (BFR-T) which only requires low training loads may allow for a faster recovery of muscle due to avoidance of high levels of mechanical muscle stress associated with high-load resistance exercise. This study aims to investigate whether BFR-T can prevent or slow down the loss of skeletal muscle mass and enhance the functional capacity and mental health of patients with pancreatic, biliary tract, and liver cancer. The PREV-Ex exercise trial is a multicenter two-armed randomized controlled trial. Patients will be randomized to an exercise program consisting of home-based low-load BFR-T during a combined pre- and postoperative period for a total of 6-10 weeks (prehabilitation and rehabilitation), or to a control group. Protein supplementation will be given to both groups to ensure adequate protein intake. The primary outcomes, skeletal muscle thickness and muscle cross-sectional area, will be assessed by ultrasound. Secondary outcomes include the following: (i) muscle catabolism-related and inflammatory bio-markers (molecular characteristics will be assessed from a vastus lateralis biopsy and blood samples will be obtained from a sub-sample of patients); (ii) patient-reported outcome measures (self-reported fatigue, health-related quality of life, and nutritional status will be assessed through validated questionnaires); (iii) physical fitness/performance/activity (validated tests will be used to evaluate physical function, cardiorespiratory fitness and maximal isometric muscle strength. Physical activity and sedentary behavior (assessed using an activity monitor); (iv) clinical outcomes: hospitalization rates and blood status will be recorded from the patients' medical records; (v) explorative outcomes of patients' experience of the exercise program which will be evaluated using focus group/individual interviews. It is worthwhile to investigate new strategies that have the potential to counteract the deterioration of skeletal muscle mass, muscle function, strength, and physical function, all of which have debilitating consequences for patients with pancreatic, biliary tract, and liver cancer. The expected findings could improve prognosis, help patients stay independent for longer, and possibly reduce treatment-related costs. ClinicalTrials.gov NCT05044065. Registered on September 14, 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Patients diagnosed with pancreatic, biliary tract, and liver cancer often suffer from a progressive loss of muscle mass. Given the considerable functional impairments in these patients, high musculoskeletal weight loads may not be well tolerated by all individuals. The use of blood-flow restricted resistance training (BFR-T) which only requires low training loads may allow for a faster recovery of muscle due to avoidance of high levels of mechanical muscle stress associated with high-load resistance exercise. This study aims to investigate whether BFR-T can prevent or slow down the loss of skeletal muscle mass and enhance the functional capacity and mental health of patients with pancreatic, biliary tract, and liver cancer.
METHODS
METHODS
The PREV-Ex exercise trial is a multicenter two-armed randomized controlled trial. Patients will be randomized to an exercise program consisting of home-based low-load BFR-T during a combined pre- and postoperative period for a total of 6-10 weeks (prehabilitation and rehabilitation), or to a control group. Protein supplementation will be given to both groups to ensure adequate protein intake. The primary outcomes, skeletal muscle thickness and muscle cross-sectional area, will be assessed by ultrasound. Secondary outcomes include the following: (i) muscle catabolism-related and inflammatory bio-markers (molecular characteristics will be assessed from a vastus lateralis biopsy and blood samples will be obtained from a sub-sample of patients); (ii) patient-reported outcome measures (self-reported fatigue, health-related quality of life, and nutritional status will be assessed through validated questionnaires); (iii) physical fitness/performance/activity (validated tests will be used to evaluate physical function, cardiorespiratory fitness and maximal isometric muscle strength. Physical activity and sedentary behavior (assessed using an activity monitor); (iv) clinical outcomes: hospitalization rates and blood status will be recorded from the patients' medical records; (v) explorative outcomes of patients' experience of the exercise program which will be evaluated using focus group/individual interviews.
DISCUSSION
CONCLUSIONS
It is worthwhile to investigate new strategies that have the potential to counteract the deterioration of skeletal muscle mass, muscle function, strength, and physical function, all of which have debilitating consequences for patients with pancreatic, biliary tract, and liver cancer. The expected findings could improve prognosis, help patients stay independent for longer, and possibly reduce treatment-related costs.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT05044065. Registered on September 14, 2021.
Identifiants
pubmed: 38835083
doi: 10.1186/s13063-024-08207-5
pii: 10.1186/s13063-024-08207-5
doi:
Banques de données
ClinicalTrials.gov
['NCT05044065']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
356Subventions
Organisme : Vetenskapsrådet
ID : 2019-06378
Organisme : Karolinska Institutet
ID : 2020-01889
Organisme : Radiumhemmets Forskningsfonder
ID : 214111
Informations de copyright
© 2024. The Author(s).
Références
Levolger S, van Vugt JL, de Bruin RW, IJzermans JN. Systematic review of sarcopenia in patients operated on for gastrointestinal and hepatopancreatobiliary malignancies. Br J Surg. 2015;102(12):1448–58.
Choi MH, Yoon SB, Lee K, Song M, Lee IS, Lee MA, et al. Preoperative sarcopenia and post-operative accelerated muscle loss negatively impact survival after resection of pancreatic cancer. J Cachexia Sarcopenia Muscle. 2018;9(2):326–34.
doi: 10.1002/jcsm.12274
pubmed: 29399990
pmcid: 5879976
Babic A, Rosenthal MH, Sundaresan TK, Khalaf N, Lee V, Brais LK, et al. Adipose tissue and skeletal muscle wasting precede clinical diagnosis of pancreatic cancer. Nat Commun. 2023;14(1):4317.
doi: 10.1038/s41467-023-40024-3
pubmed: 37463915
pmcid: 10354105
Penna F, Ballaro R, Beltra M, De Lucia S, Garcia Castillo L, Costelli P. The Skeletal Muscle as an Active Player Against Cancer Cachexia. Front Physiol. 2019;10:41.
doi: 10.3389/fphys.2019.00041
pubmed: 30833900
pmcid: 6387914
Gleeson M, Bishop NC, Stensel DJ, Lindley MR, Mastana SS, Nimmo MA. The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease. Nat Rev Immunol. 2011;11(9):607–15.
doi: 10.1038/nri3041
pubmed: 21818123
Padilha CS, Testa MT, Marinello PC, Cella PS, Voltarelli FA, Frajacomo FT, et al. Resistance exercise counteracts tumor growth in two carcinoma rodent models. Med Sci Sports Exerc. 2019;51(10):2003–11.
doi: 10.1249/MSS.0000000000002009
pubmed: 30985506
Wiskemann J, Clauss D, Tjaden C, Hackert T, Schneider L, Ulrich CM, et al. Progressive resistance training to impact physical fitness and body weight in pancreatic cancer patients: a randomized controlled trial. Pancreas. 2019;48(2):257–66.
doi: 10.1097/MPA.0000000000001221
pubmed: 30589829
Steindorf K, Clauss D, Tjaden C, Hackert T, Herbolsheimer F, Bruckner T, et al. Quality of life, fatigue, and sleep problems in pancreatic cancer patients-a randomized trial on the effects of exercise. Dtsch Arztebl Int. 2019;116(27–28):471–8.
pubmed: 31431236
pmcid: 6718894
Denlinger CS, Hall MJ, Cohen SJ, Astsaturov IA, Dotan E, Engstrom PF, et al. Physical activity intervention for patients with advanced pancreatic cancer. J Clin Oncol. 2017;35(5_suppl):217.
doi: 10.1200/JCO.2017.35.5_suppl.217
Centner C, Wiegel P, Gollhofer A, Konig D. Correction to: Effects of blood flow restriction training on muscular strength and hypertrophy in older individuals: a systematic review and meta-analysis. Sports Med. 2019;49(1):109–11.
doi: 10.1007/s40279-018-1013-2
pubmed: 30414044
Jorgensen AN, Aagaard P, Frandsen U, Boyle E, Diederichsen LP. Blood-flow restricted resistance training in patients with sporadic inclusion body myositis: a randomized controlled trial. Scand J Rheumatol. 2018;47(5):400–9.
doi: 10.1080/03009742.2017.1423109
pubmed: 29775118
Wooten SV, Fleming RYD, Wolf JS Jr, Stray-Gundersen S, Bartholomew JB, Mendoza D, et al. Prehabilitation program composed of blood flow restriction training and sports nutrition improves physical functions in abdominal cancer patients awaiting surgery. Eur J Surg Oncol. 2021;47(11):2952–8.
doi: 10.1016/j.ejso.2021.05.038
pubmed: 34092455
Starkey DB, Pollock ML, Ishida Y, Welsch MA, Brechue WF, Graves JE, et al. Effect of resistance training volume on strength and muscle thickness. Med Sci Sports Exerc. 1996;28(10):1311–20.
doi: 10.1097/00005768-199610000-00016
pubmed: 8897390
Abiko T, Ohmae K, Murata S, Shiraiwa K, Horie J. Reliability of muscle thickness and echo intensity measurements of the quadriceps: a novice examiner. J Bodyw Mov Ther. 2022;31:164–8.
doi: 10.1016/j.jbmt.2022.03.004
pubmed: 35710216
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.
doi: 10.1093/jnci/85.5.365
pubmed: 8433390
Weis J, Tomaszewski KA, Hammerlid E, Ignacio Arraras J, Conroy T, Lanceley A, et al. International psychometric validation of an EORTC quality of life module measuring cancer related fatigue (EORTC QLQ-FA12). Natl. Cancer Inst. 2017;109. https://doi.org/10.1093/jnci/djw273 .
Minton O, Stone P. A systematic review of the scales used for the measurement of cancer-related fatigue (CRF). Ann Oncol. 2009;20(1):17–25.
doi: 10.1093/annonc/mdn537
pubmed: 18678767
Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002;56(8):779–85.
doi: 10.1038/sj.ejcn.1601412
pubmed: 12122555
Bjorkman F, Ekblom O, Ekblom-Bak E, Bohman T. The ability of a submaximal cycle ergometer test to detect longitudinal changes in VO(2)max. BMC Sports Sci Med Rehabil. 2021;13(1):156.
doi: 10.1186/s13102-021-00387-w
pubmed: 34906224
pmcid: 8670613
Hawley JA, Noakes TD. Peak power output predicts maximal oxygen uptake and performance time in trained cyclists. Eur J Appl Physiol Occup Physiol. 1992;65(1):79–83.
doi: 10.1007/BF01466278
pubmed: 1505544
Bergstrom J. Percutaneous needle biopsy of skeletal muscle in physiological and clinical research. Scand J Clin Lab Invest. 1975;35(7):609–16.
doi: 10.3109/00365517509095787
pubmed: 1108172
Mijwel S, Cardinale DA, Norrbom J, Chapman M, Ivarsson N, Wengstrom Y, et al. Exercise training during chemotherapy preserves skeletal muscle fiber area, capillarization, and mitochondrial content in patients with breast cancer. FASEB J. 2018;32(10):5495–505.
doi: 10.1096/fj.201700968R
pubmed: 29750574
Arthur AE, Delk A, Demark-Wahnefried W, Christein JD, Contreras C, Posey JA 3rd, et al. Pancreatic cancer survivors’ preferences, barriers, and facilitators related to physical activity and diet interventions. J Cancer Surviv. 2016;10(6):981–9.
doi: 10.1007/s11764-016-0544-5
pubmed: 27138993
pmcid: 5086446
Steins Bisschop CN, Courneya KS, Velthuis MJ, Monninkhof EM, Jones LW, Friedenreich C, et al. Control group design, contamination and drop-out in exercise oncology trials: a systematic review. PLoS ONE. 2015;10(3):e0120996.
doi: 10.1371/journal.pone.0120996
pubmed: 25815479
pmcid: 4376879