Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.
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SUBMITTER: Garcia-Delgado Y
PROVIDER: S-EPMC8465022 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPrevious studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies.PurposeThe EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity.Material and methodsThe EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7-14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery.ConclusionThe EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery.Trial registrationEFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018.
| S-EPMC8458203 | biostudies-literature
Project description:BACKGROUND:The expansion of digital devices and widespread access to the Internet has opened up opportunities to provide patients with more personal information. It can be hypothesized that eHealth in addition to standard care could enhance clinical outcomes such as increased weight loss, co-morbidity reduction, and commitment to the program. The beneficial value of incorporating eHealth applications as standard postoperative care is yet to be established. In this trial, the value of different levels of eHealth are assessed. METHODS/DESIGN:Two hundred adult patients with a body mass index (BMI) ??40 kg/m2, or ??35 kg/m2 with obesity-related co-morbidity, undergoing sleeve gastrectomy or gastric bypass will be enrolled in this randomized controlled trial. Patients will be randomly assigned to one of the groups: receiving standard care (control group, n =?100); have access to an online eHealth platform in addition to the previous group (online group, n =?50); or receive wireless monitoring devices in addition to previous groups (device group, n =?50). The total follow-up period is two years postoperatively. Primary outcome is weight loss in terms of BMI. Secondary outcomes include: quality of life; return-to-work time; co-morbidity reduction; additional contacts; and ease of use of devices. DISCUSSION:In this trial, the value of different levels of eHealth will be assessed. This addresses an important aspect of a changing healthcare environment. TRIAL REGISTRATION:Trialregister.nl, NTR6827. Retrospectively registered on 19 November 2017. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6827 .
| S-EPMC6237032 | biostudies-literature
Project description:BackgroundObesity is associated with a chronic systemic inflammatory process. Volatile or intravenous anesthetic agents may modulate immune function, and may do so differentially in obesity. However, no study has evaluated whether these potential immunomodulatory effects differ according to type of anesthesia in obese patients undergoing laparoscopic bariatric surgery.Methods/designThe OBESITA trial is a prospective, nonblinded, single-center, randomized, controlled clinical pilot trial. The trial will include 48 patients with a body mass index ≥ 35 kg/m2, scheduled for laparoscopic bariatric surgery using sleeve or a Roux-en-Y gastric bypass technique, who will be allocated 1:1 to undergo general inhalational anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol. The primary endpoint is the difference in plasma interleukin (IL)-6 levels when comparing the two anesthetic agents. Blood samples will be collected prior to anesthesia induction (baseline), immediately after anesthetic induction, and before endotracheal extubation. Levels of other proinflammatory and anti-inflammatory cytokines, neutrophil chemotaxis, macrophage differentiation, phagocytosis, and occurrence of intraoperative and postoperative complications will also be evaluated.DiscussionTo our knowledge, this is the first randomized clinical trial designed to compare the effects of two different anesthetics on immunomodulation in obese patients undergoing laparoscopic bariatric surgery. Our hypothesis is that anesthesia with sevoflurane will result in a weaker proinflammatory response compared to anesthesia with propofol, with lower circulating levels of IL-6 and other proinflammatory mediators, and increased macrophage differentiation into the M2 phenotype in adipose tissue.Trial registrationRegistro Brasileiro de Ensaios Clínicos, RBR-77kfj5 . Registered on 25 July 2018.
| S-EPMC6540380 | biostudies-literature
Project description:Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention program on the improvement of clinical parameters and functional physical capacity in patients undergoing surgery for lumbar spinal stenosis.Forty patients will be recruited and randomly allocated to one of the 2 treatment arms: 6 weeks supervised preoperative rehabilitation program (experimental group) or hospital standard preoperative management (control group). The intervention group will be trained three times per week, with each session aiming to improve strength, muscular endurance, spinal stabilization and cardiovascular fitness. Intensity and complexity of exercises will be gradually increased throughout the sessions, depending on each participant's individual progress. Primary outcomes are level of low back disability and level of pain. Secondary outcomes include the use of pain medication, quality of life, patient's global impression of change, lumbar extensor muscles endurance, maximum voluntary contraction of lumbar flexor and extensor muscles, maximum voluntary contraction of knee extensors, active lumbar ranges of motion, walking abilities, and cardiovascular capacity. Both the primary and secondary outcomes will be measured at baseline, at the end of the training program (6 weeks after baseline evaluation for control participants), and at 6 weeks, 3 and 6 months postoperatively.This study will inform the design of a future large-scale trial. Improvements of physical performances before undergoing lumbar surgery may limit functional limitations occurring after a surgical intervention. Results of this study will provide opportunity to efficiently improve spinal care and advance our knowledge of favorable preoperative strategies to optimize postoperative recovery.US National Institutes of Health Clinical Trials registry NCT02258672 , 10 February 2014.
| S-EPMC4623294 | biostudies-literature
Project description:BackgroundBariatric surgery is an effective approach to weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not been systematically prescribed after bariatric surgery. The aim of this study is to determine the effects of two types of exercise, moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT), on body composition, cardiopulmonary function, and perceived quality of life in bariatric surgery patients.MethodsThis randomized controlled exploratory pilot trial will include 75 adults of both sexes scheduled for bariatric surgery. They will be randomly assigned to one of three groups: (1) MICT, (2) HIIT, or (3) a control group. The intervention will occur 2?days a week for 4?months. Outcomes will be assessed at four points: (1) 1 week before surgery, (2) 21?days after surgery (baseline before the exercise program), (3) 8?weeks after beginning the exercise program, and (4) 1 week after the end of intervention. Primary outcomes will include body composition, heart rate variability, and 6-min walk test and quality of life scores. Secondary outcomes will be maximal respiratory pressure, flowmeter, hand dynamometry, and 30-s sit-to-stand test results.DiscussionBoth exercise protocols in this study were developed according to evidence-based practice. It is expected that, after 16?weeks of intervention, body composition (measured by electrical bioimpedance), cardiopulmonary function (measured by heart rate variability, maximal inspiratory pressure, maximal expiratory pressure, peak expiratory flow, handgrip strength, and the 6-min walk test), and perceived quality of life (measured by the Moorehead-Ardelt quality of life questionnaire II and bariatric analysis and reporting outcome system scores) will improve, especially in the HIIT group.Trial registrationClinicalTrials.gov NCT04235842 . Registered on 22 January 2020.
| S-EPMC7849097 | biostudies-literature
Project description:Psychosocial interventions can improve eating behaviours and psychosocial functioning in bariatric surgery candidates. However, those that involve face-to-face sessions are problematic for individuals with severe obesity due to mobility issues and practical barriers.To examine the efficacy of a pre-operative telephone-based cognitive behavioural therapy (Tele-CBT) intervention versus standard pre-operative care for improving eating psychopathology and psychosocial functioning.Preoperative bariatric surgery patients (N = 47) were randomly assigned to receive standard preoperative care (n = 24) or 6 sessions of Tele-CBT (n = 23).Retention was 74.5% at post-intervention. Intent-to-treat analyses indicated that the Tele-CBT group reported significant improvements on the Binge Eating Scale (BES), t (22) = 2.81, p = .01, Emotional Eating Scale (EES), t (22) = 3.44, p = .002, and Patient Health Questionnaire-9 (PHQ-9), t (22) = 2.71, p = .01, whereas the standard care control group actually reported significant increases on the EES, t (23) = 4.86, p < .001, PHQ-9, t (23) = 2.75, p = .01, and General Anxiety Disorder-7 (GAD-7), t (23) = 2.93, p = .008 over the same time period.Tele-CBT holds promise as a brief intervention for improving eating psychopathology and depression in bariatric surgery candidates.
| S-EPMC5468091 | biostudies-literature
Project description:BackgroundObesity represents a major public health problem and is the fifth leading risk factor for mortality. Morbid obesity is associated with chronic systemic inflammation which increases the risk of comorbidities. Bariatric surgery (BS) is considered an effective intervention for obese patients. However, BS is associated with dietary restriction, potentially limiting physical activity. Whole-body neuromuscular electrical stimulation (WBS) could represent an innovative option for the rehabilitation of BS patients, especially during the early postoperative phase when other conventional techniques are contraindicated. WBS is a safe and effective tool to combat sarcopenia and metabolic risk as well as increasing muscle mass, producing greater glucose uptake, and reducing the proinflammatory state. Therefore, the objective of this study is to evaluate the effects of WBS on body composition, functional capacity, muscle strength and endurance, insulin resistance, and pro- and anti-inflammatory circulating markers in obese patients undergoing BS.Methods/designThe present study is a randomized, double-blind, placebo-controlled, parallel groups clinical trial approved by the Ethics Committee of our Institution. Thirty-six volunteers (body mass index (BMI)?>?35 kg/m2) between 18 and 45 years of age will be randomized to the WBS group (WBSG) or control (Sham) group (ShamG) after being submitted to BS. Preoperative assessments will include maximal and submaximal exercise testing, body composition, blood inflammatory markers, and quadriceps strength and endurance. The second day after discharge, body composition will be evaluated and a 6-min walk test (6MWT) will be performed. The WBS or Sham protocol will consist of 30 daily sessions for 6 consecutive weeks. Afterwards, the same assessments that were performed in the preoperative period will be repeated.DiscussionConsidering the important role of WBS in skeletal muscle conditioning and its value as an aid in exercise performance, the proposed study will investigate this technique as a tool to promote early rehabilitation in these patients, and as a strategy to enhance exercise capacity, weight loss, and peripheral muscle strength with positive systemic effects. The present study is still ongoing, and data will be published after its conclusion.Trial registrationREBEC, RBR-99qw5h . Registered on 20 February 2015.
| S-EPMC6211515 | biostudies-literature
Project description:BACKGROUND:Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial. METHODS/DESIGN:This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate the efficacy and safety of electroacupuncture in managing postoperative pain following nasal endoscopic surgery to treat sinusitis due to nasal polyps. Altogether, 30 participants will be randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will occur within 2?h before the operation, immediately after the operation upon arrival in the recovery ward, and once daily for 3?days. The primary outcome is the pain numerical rating scale, which will be analyzed using the area under the curve. The secondary outcome measures include heart rate and blood pressure after the operation, sleep quality during the hospital stay (actigraph), quality of recovery, and the 36-item short form health survey. This trial will use an intention-to-treat analysis. DISCUSSION:This pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR1900024183. Registered on 29 June 2019.
| S-EPMC7014590 | biostudies-literature
Project description:SettingBariatric surgery is indicated for patients diagnosed with obesity and type 2 diabetes. Many patients achieve type 2 diabetes remission soon after bariatric surgery. Even though most maintain good glycemic control, remission is not maintained in all patients, and as a result, some patients may relapse. Type 2 diabetes relapse is common in patients who regain weight; weight regain is prevalent 1 to 2 years after surgery. Additional pharmacotherapy may be required to aid bariatric surgery in fostering weight loss and reducing blood glucose levels.ObjectivesThe purpose of this clinical trial was to determine the effects of canagliflozin in participants who initially achieved type 2 diabetes remission but subsequently relapsed.MethodsThe double-blinded, randomized, and prospective study recruited participants (n = 16) roughly 3 years after bariatric surgery. The participants were followed for 6 months.ResultsBody mass index (-1.24 kg/m2) and body weight (-3.7 kg) were significantly reduced with canagliflozin therapy versus placebo. There were improvements in body fat composition as denoted by reductions in android (-3.00%) and truncal (-2.67%) fat. Also, there were differences in blood glucose and hemoglobin A1C at 6 months.ConclusionAfter bariatric surgery, canagliflozin improved weight loss and glycemic outcomes in participants with type 2 diabetes. Canagliflozin also facilitated improvements in body fat composition.
| S-EPMC7278903 | biostudies-literature
Project description:An emerging field of research describes the role of preoperative health behaviours, known as prehabilitation. The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours, such as exercise, in patients compared to post-treatment during recovery. Moreover, physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects. No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy.This is a multi-centre, pilot randomized control trial conducted at two Canadian urban teaching hospitals. 100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care. Prehabilitation participants will engage in a preoperative, individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer. These participants will be asked to engage in 60 minutes of home-based, unsupervised, moderate-intensity exercise on 3-4 days per week. Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only. We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate, programmatic adherence/contamination, attrition, and safety. Estimates of intervention efficacy will be captured through measurements at baseline (4-8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Efficacy outcomes include: fatigue, quality of life, urinary incontinence, physical fitness, body composition, aerobic fitness, pain, and physical activity volume.The primary outcome of this study is to determine the feasibility of conducting a full-scale, randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field. To our knowledge, this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer. This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery.Clinicaltrials.gov Identifier: NCT02036684.
| S-EPMC4246547 | biostudies-literature