Dataset Information

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study.

ABSTRACT:

Background

Morbidity rates in pancreatic surgery are high, and frail patients with low aerobic capacity are especially at risk of complications and require prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes.

Objective

In this study, we aim to assess the feasibility of a home-based exercise prehabilitation program in unfit patients scheduled for pancreatic surgery on a larger scale.

Methods

In this multicenter study, adult patients scheduled for elective pancreatic surgery with a preoperative oxygen uptake (VO₂) at the ventilatory anaerobic threshold ≤13 mL/kg/min or a VO₂ at peak exercise ≤18 mL/kg/min will be recruited. A total of 30 patients will be included in the 4-week, home-based, partly supervised exercise prehabilitation program. The program comprises 25-minute high-intensity interval training on an advanced cycle ergometer 3 times a week. Training intensity will be based on steep ramp test performance (ie, a short-term maximal exercise test on a cycle ergometer), aiming to improve aerobic capacity. Twice a week, patients will perform functional task exercises to improve muscle function and functional mobility. A steep ramp test will be repeated weekly, and training intensity will be adjusted accordingly. Next to assessing the feasibility (participation rate, reasons for nonparticipation, adherence, dropout rate, reasons for dropout, adverse events, and patient and therapist appreciation) of this program, individual patients' responses to prehabilitation on aerobic capacity, functional mobility, body composition, quality of life, and immune system factors will be evaluated.

Results

Recruitment for this study began in January 2022 and is expected to be completed in the summer of 2023.

Conclusions

Results of this study will provide important clinical and scientific knowledge on the feasibility of a partly supervised home-based exercise prehabilitation program in a vulnerable patient population. This might ease the path to implementing prehabilitation programs in unfit patients undergoing complex abdominal surgery, such as pancreatic surgery.

Trial registration

ClinicalTrials.gov NCT05496777; https://classic.clinicaltrials.gov/ct2/show/NCT05496777.

International registered report identifier (irrid)

DERR1-10.2196/46526.

SUBMITTER: Hildebrand ND

PROVIDER: S-EPMC10514766 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study.

Hildebrand Nicole D ND Wijma Allard G AG Bongers Bart C BC Rensen Sander S SS den Dulk Marcel M Klaase Joost M JM Olde Damink Steven W M SWM

JMIR research protocols 20230907

<h4>Background</h4>Morbidity rates in pancreatic surgery are high, and frail patients with low aerobic capacity are especially at risk of complications and require prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes.<h4>Objective</h4>In this study, we aim to assess the feasibility of a home-based exercise prehabilitation program ...[more]

PMID: 37676715

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Project description:BackgroundPreoperative anemia is a frequent complication in pancreatic surgical patients, and it adversely affects morbidity, mortality, and postoperative red blood cell (RBC) transfusion rates. Iron deficiency (ID) is often the underlying cause of anemia and constitutes a modifiable risk factor.MethodsSingle-center, longitudinal prospective cohort study conducted between May 2019 and August 2022 at the University Medical Center Groningen in the Netherlands. Patients scheduled for pancreatic surgery were referred to the outpatient prehabilitation clinic for preoperative optimization of patient-related risk factors. Patients were screened for anemia (< 12.0 g/dL in women and < 13.0 g/dL in men) and ID (either absolute [ferritin < 30 µg/L] or functional [ferritin ≥ 30 µg/L + transferrin saturation < 20% + C-reactive protein > 5 mg/L]). Intravenous iron supplementation (IVIS) (1,000 mg ferric carboxymaltose) was administered to patients with ID at the discretion of the consulting internist. Pre- and postoperative hemoglobin (Hb) levels were assessed, and perioperative outcomes were compared between patients receiving IVIS (IVIS-group) or standard care (SC-group).ResultsFrom 164 screened patients, preoperative anemia was observed in 55 (33.5%) patients, and in 23 (41.8%) of these patients, ID was the underlying cause. In 21 patients, ID was present without concomitant anemia. Preoperative IVIS was administered to 25 patients, out of 44 patients with ID. Initial differences in mean Hb levels (g/dL) between the IVIS-group and SC-group at the outpatient clinic and one day prior to surgery (10.8 versus 13.2, p < 0.001, and 11.8 versus 13.4, p < 0.001, respectively) did not exist at discharge (10.6 versus 11.1, p = 0.13). Preoperative IVIS led to a significant increase in mean Hb levels (from 10.8 to 11.8, p = 0.03). Fewer SSI were observed in the IVIS-group (4% versus 25.9% in the SC-group, p = 0.02), which remained significant in multivariable regression analysis (OR 7.01 (1.68 - 49.75), p = 0.02).ConclusionID is prevalent in patients scheduled for pancreatic surgery and is amendable to preoperative correction. Preoperative IVIS increased Hb levels effectively and reduced postoperative SSI. Screening and correction of ID is an important element of preoperative care and should be a standard item in daily prehabilitation practice.

Project description:BackgroundPatients presenting for major surgery with low cardiorespiratory fitness (deconditioning) and other modifiable risk factors are at increased risk of postoperative complications. This study investigated the feasibility of delivering prehabilitation in high-risk patients scheduled for major abdominal cancer surgery.MethodsEligible patients in this single-center cohort study included patients with poor fitness (objectively assessed by cardiopulmonary exercise testing, CPET) scheduled for elective major abdominal cancer surgery. Patients were recruited to participate in a prehabilitation program that spanned up to 6 weeks pre-operatively and comprised aerobic and resistance exercise training, breathing exercise, and nutritional support. The primary outcome assessed pre-specified feasibility targets: recruitment >70%, retention >85%, and intervention adherence >70%. Secondary outcomes were assessed for improved pre-operative functional status and health-related quality of life and for postoperative complications.ResultsEighty-two (34%) out of 238 patients screened between April 2018 and December 2019 were eligible for recruitment. Fifty (61%) patients (52% males) with a median age of 71 (IQR, 63-77) years participated in the study. Baseline oxygen consumption the at anaerobic threshold and at peak exercise (mean±SD: 9.8±1.8 and 14.0±2.9 mL/kg/min, respectively) confirmed the deconditioned state of the study cohort. The retention rate within the prehabilitation program was 84%, with 42 participants returning for repeat CPET testing. While >60% of participants preferred to do home-based prehabilitation, adherence to the intervention was low-with only 12 (28%) and 15 (35%) of patients having self-reported compliance >70% with their exercise prescriptions.ConclusionOur prehabilitation program in high-risk cancer surgery patients did not achieve pre-specified targets for recruitment, retention, and self-reported program adherence. These findings underpin the importance of implementation research and strategies for the prehabilitation programs in major surgery.Trial registrationAustralian New Zealand Clinical Trials Registry ( ACTRN12620000073909 ) retrospectively registered.

Project description:BackgroundTreatment 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, postoperative 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.MethodsWe recruited patients to a single-arm feasibility trial of home-based exercise prehabilitation. Eligible patients were aged ≥18years, 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) and (d) compliance with exercise sessions, exercise intensity and strengthening exercises.ResultsThere were 42 patients recruited, and 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).ConclusionsThe results of this trial support the feasibility and acceptability of recruiting participants to an appropriately powered randomised controlled trial of prehabilitation.Trial registrationClinicaltrials.gov NCT04194463 . Registered on 11th December 2019-retrospectively registered.

Project description:Preoperative physical exercise is emerging as a growing field of research globally. There are still challenges in recruiting vulnerable older people, and time constraints in preoperative cancer care to consider. We therefore evaluated the feasibility of short-term supervised home-based exercise in older people prior to colorectal cancer surgery. This feasibility study was conducted between September 2016 and June 2018. People ≥70 years scheduled for colorectal cancer surgery were recruited and randomized to an intervention group receiving supervised home-based physical exercise at a high level of estimated exertion or a standard care group following the standard preoperative path. The exercise (respiratory, strength, and aerobic) consisted of 2-3 supervised sessions a week in the participants' homes, for at least 2-3 weeks or until surgery, and a self-administered exercise program in between. The primary outcome was process feasibility, including aspects specifically related to recruitment rate, compliance to the intervention, and acceptability. The secondary outcome was scientific feasibility including treatment safety, description of dose level and response, and estimation of treatment results. Twenty-three participants were included (recruitment rate 35%). A median of 6 supervised sessions was conducted over a 17-day exercise period. Compliance with the supervised sessions was 97%, and participants found the intervention acceptable. Concerning the self-administered exercise, a median of 19 inspiratory muscle training, 6 functional strength, and 8.5 aerobic sessions were reported. Challenges reported by program instructors were time constraints and difficulties in achieving high exercise intensities on the Borg CR-10 scale. A statistically significant between-group difference was only found in inspiratory muscle strength, favoring the intervention group (p<0.01). A short-term preoperative supervised home-based physical exercise intervention can be conducted, with respect to compliance and acceptability, in older people with similar physical status as in this study prior to colorectal cancer surgery. However, modifications are warranted with respect to improving recruitment rates and achieving planned intensity levels prior to conducting a definitive trial.

Project description:ObjectiveThis study aims to explore the feasibility, safety, and effectiveness of home exercise prehabilitation on a new social platform for remote guidance to optimize the physical function of patients with end-stage renal disease awaiting kidney transplantation and provide scientific guidance on home prehabilitation exercises for patients awaiting kidney transplantation.MethodsThe subjects of this randomized clinical trial were randomly divided into the test and control groups. The control group maintained their exercise habits, while the trial group was given a 12-week personalized home prehabilitation exercise prescription (aerobic exercise + functional resistance exercise + flexibility exercise) on a new social platform with remote guidance. The participants' physical and cardiorespiratory fitness, quality of life, and psychological functioning were assessed before and after the intervention. The 6-min walk test (6MWT) walking distance and its percentage of attainment, the handgrip, the 5 repetition-sit-to-stand test, and the 4-m gait speed were used as primary outcome indicators, while the Short Form Health Survey SF-36 (health survey summary table) and the Hospital Anxiety and Depression scale were used as the secondary outcome indicators.ResultsAfter 12 weeks of intervention, the changes in the 6MWT measured distance (+ 44.9 ± 40.2, P = 0.001) and the percentage of 6MWT measured distance achieved (+ 6.8 ± 5.7, P = 0.001), the handgrip (+ 2.7 ± 4.3, P = 0.028), the 5-sit-to-stand test (-1.1 ± 1.4, P = 0.005), and the 4-m walking speed (-0.3 ± 0.4, P < 0.001) of the test group (n = 21) improved significantly. In the control group (n = 16), the changes in the 6MWT measured distance (-13.1 ± 57.2), the 6MWT measured distance attainment percentage (-2.1 ± 9.1), the handgrip (-0.1 ± 2.5), the 5-sit-to-stand test value (0.6 ± 2.2), and the 4-m walking speed (0.2 ± 0.5) showed no significant difference. No significant improvement in anxiety, depression, and SF-36 was noted in both the test and control groups.ConclusionThe remote coaching of home exercise pre-habilitation on a new social platform significantly improves the physical and cardiopulmonary fitness of patients with end-stage renal disease awaiting kidney transplantation. This treatment is safe and feasible in this population.

Project description:ObjectiveTo assess the effects of a 3-week community-based exercise program on 30-day postoperative complications in high-risk patients scheduled for elective colorectal resection for (pre)malignancy.Summary background dataPatients with a low preoperative aerobic fitness undergoing colorectal surgery have an increased risk of postoperative complications. It remains, however, to be demonstrated whether prehabilitation in these patients reduces postoperative complications.MethodsThis 2-center, prospective, single-blinded randomized clinical trial was carried out in 2 large teaching hospitals in the Netherlands. Patients (≥60 years) with colorectal (pre)malignancy scheduled for elective colorectal resection and with a score ≤7 metabolic equivalents on the veterans-specific activity questionnaire were randomly assigned to the prehabilitation group or the usual care group by using block-stratified randomization. An oxygen uptake at the ventilatory anaerobic threshold <11 mL/kg/min at the baseline cardiopulmonary exercise test was the final inclusion criterion. Inclusion was based on a power analysis. Patients in the prehabilitation group participated in a personalized 3-week (3 sessions per week, nine sessions in total) supervised exercise program given in community physical therapy practices before colorectal resection. Patients in the reference group received usual care. The primary outcome was the number of patients with one or more complications within 30 days of surgery, graded according to the Clavien-Dindo classification. Data were analyzed on an intention-to-treat basis.ResultsBetween February 2014 and December 2018, 57 patients [30 males and 27 females; mean age 73.6 years (standard deviation 6.1), range 61-88 years] were randomized to either prehabilitation (n = 28) or usual care (n = 29). The rate of postoperative complications was lower in the prehabilitation group (n = 12, 42.9%) than in the usual care group (n = 21, 72.4%, relative risk 0.59, 95% confidence interval 0.37-0.96, P = 0.024).ConclusionsExercise prehabilitation reduced postoperative complications in high-risk patients scheduled to undergo elective colon resection for (pre)malignancy. Prehabilitation should be considered as usual care in high-risk patients scheduled for elective colon, and probably also rectal, surgery.

Dataset Information

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study.

Similar Datasets

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