Dataset Information

Feasibility and acceptability of a preoperative exercise program for patients undergoing major cancer surgery: results from a pilot randomized controlled trial.

ABSTRACT:

Objective

To establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial.

Design

Pilot randomized controlled trial.

Setting

Royal Prince Alfred Hospital, Sydney, Australia.

Subjects

We included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80?years, who presented to the participating gastrointestinal surgeon at least 2?weeks prior to surgery. Patients presenting cognitive impairment, co-morbidity preventing participation in exercise, inadequate English language, currently participating in an exercise program or unable to attend the exercise program sessions were excluded.

Methods

Participants were randomized to a 2-6?weeks preoperative, face-to-face, individualised exercise program or to usual care. Feasibility was assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the preoperative exercise program. Acceptability of the exercise program was assessed with a semi-structured questionnaire exploring the advice received and the amount, duration and intensity of the exercise program. In addition, postoperative complication rates (Clavien-Dindo), length of hospital stay and self-reported measures of health-related quality of life (SF-36v2) were collected at baseline, day before surgery and in-hospital up to discharge from hospital.

Results

Of 122 patients screened, 26 (21%) were eligible and 22 (85%) accepted to participate in the trial and were randomized to the intervention (11; 50%) or control group (11; 50%). The median age of the include participants was 63?years. Adherence to the preoperative exercise sessions was 92.7%, with all participants either satisfied (33%) or extremely satisfied (67%) with the overall design of the preoperative exercise program. No significant differences in outcomes were found between groups.

Conclusions

The results of our pilot trial demonstrate that a preoperative exercise program is feasible and acceptable to patients undergoing major abdominal cancer surgery. There is an urgent need for a definite trial investigating the effectiveness of a preoperative exercise program on postoperative outcomes in patients undergoing major abdominal cancer surgery. This could potentially reduce postoperative complication rates, length of hospital stay and subsequently overall health care costs.

Trial registration

ACTRN12617001129370. Registered on August 1, 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true.

SUBMITTER: Steffens D

PROVIDER: S-EPMC7805142 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Feasibility and acceptability of a preoperative exercise program for patients undergoing major cancer surgery: results from a pilot randomized controlled trial.

Steffens Daniel D Young Jane J Beckenkamp Paula R PR Ratcliffe James J Rubie Freya F Ansari Nabila N Pillinger Neil N Koh Cherry C Munoz Phillip A PA Solomon Michael M

Pilot and feasibility studies 20210113 1

<h4>Objective</h4>To establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial.<h4>Design</h4>Pilot randomized controlled trial.<h4>Setting</h4>Royal Prince Alfred Hospital, Sydney, Australia.<h4>Subjects</h4>We included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80 years, who presented to the parti ...[more]

PMID: 33441181

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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:Background Preoperative anemia is associated with an increased need for blood transfusion, complications, and prolonged hospital stay. Iron deficiency anemia (IDA) may be treated with oral or intravenous (IV) iron. IV iron repletes iron stores more rapidly. Its impact on perioperative blood transfusion, postoperative complications, patients' recovery, and long-term quality of life is unclear. Newer agents, such as ferric carboxymaltose (FCM), are costly but have higher maximum approved doses and a very low incidence of anaphylactic-type reactions. This study aims to explore the feasibility of a randomized control trial to compare the preoperative treatment of IDA with IV FCM versus oral ferrous fumarate, in patients undergoing elective major abdominal surgery. Experimental design This is an open-label pilot randomized controlled trial. A total of 30 adults with IDA scheduled for elective major abdominal surgery were recruited for the study. They were randomized into two groups to receive either oral iron or IV FCM. Primary outcomes are defined as the time from enrollment to study drug administration, recruitment rate, and follow-up rate up to three months. Secondary outcomes are hemoglobin rise from recruitment to surgery, perioperative blood transfusion, postoperative complications, EQ-5D-3L scores at baseline, and three months and adverse events related to IV FCM therapy. Results All patients received study drugs within five days of enrollment; 30 patients were recruited within four months, 15 patients in each group. Two in each group were withdrawn for surgery postponement. All patients were followed up for three months and there was no crossover of patients. Per protocol, analysis was performed. No severe adverse events related to IV FCM therapy occurred. Both groups had similar baseline characteristics, similar hemoglobin rise from enrollment to the day of surgery [0.2 (+1.6) g/dL in the FCM group and 0.8 (+0.7) g/dL in the Oral Iron group, p=0.3] and similar mean units of perioperative blood transfused (recruitment to discharge) per patient [1.3 (+ 2.1) in the FCM group and 0.9 (+1.3) in the Oral Iron group, p=0.6]. Postoperatively, there was a similar hospital length of stay [11.5 (+13.6 days) in the FCM group and 9.0 (+9.8 days) in the Oral Iron group, p=0.6]; there were similar postoperative complications as reflected by the average Comprehensive Complication Index [12.8 (+19.6) in the FCM group and 22.6 (+30.7) in the Oral Iron group, p=0.3]; similar postoperative health-related quality of life as reflected by mean EQ-5D-3L scores at one month [70.4 (+21.8) in the FCM group and 84.5 (+12.1) in the Oral Iron group] and three months [80.0 (+18.4) in the FCM group and 85.9 (+10.7) in the Oral Iron group]. Conclusions A full-scale randomized controlled trial to evaluate the effectiveness of preoperative IV FCM compared to oral iron in patients with IDA undergoing major abdominal surgery is feasible.

Project description:BackgroundMajor surgery is associated with negative postoperative outcomes such as complications and delayed or poor recovery. Multimodal prehabilitation can help to reduce the negative effects of major surgery. Offering prehabilitation by means of mobile health (mHealth) could be an effective new approach.ObjectiveThe objectives of this pilot study were to (1) evaluate the usability of the Be Prepared mHealth app prototype for people undergoing major surgery, (2) explore whether the app was capable of bringing about a change in risk behaviors, and (3) estimate a preliminary effect of the app on functional recovery after major surgery.MethodsA mixed-methods pilot randomized controlled trial was conducted in two Dutch academic hospitals. In total, 86 people undergoing major surgery participated. Participants in the intervention group received access to the Be Prepared app, a smartphone app using behavior change techniques to address risk behavior prior to surgery. Both groups received care as usual. Usability (System Usability Scale), change in risk behaviors 3 days prior to surgery, and functional recovery 30 days after discharge from hospital (Patient-Reported Outcomes Measurement Information System physical functioning 8-item short form) were assessed using online questionnaires. Quantitative data were analyzed using descriptive statistics, chi-square tests, and multivariable linear regression. Semistructured interviews about the usability of the app were conducted with 12 participants in the intervention group. Thematic analysis was used to analyze qualitative data.ResultsSeventy-nine people-40 in the intervention group and 39 in the control group-were available for further analysis. Participants had a median age of 61 (interquartile range 51.0-68.0) years. The System Usability Scale showed that patients considered the Be Prepared app to have acceptable usability (mean 68.2 [SD 18.4]). Interviews supported the usability of the app. The major point of improvement identified was further personalization of the app. Compared with the control group, the intervention group showed an increase in self-reported physical activity and muscle strengthening activities prior to surgery. Also, 2 of 2 frequent alcohol users in the intervention group versus 1 of 9 in the control group drank less alcohol in the run-up to surgery. No difference was found in change of smoking cessation. Between-group analysis showed no meaningful differences in functional recovery after correction for baseline values (β=-2.4 [95% CI -5.9 to 1.1]).ConclusionsThe Be Prepared app prototype shows potential in terms of usability and changing risk behavior prior to major surgery. No preliminary effect of the app on functional recovery was found. Points of improvement have been identified with which the app and future research can be optimized.Trial registrationNetherlands Trial Registry NL8623; https://www.trialregister.nl/trial/8623.

Project description:BackgroundThe purpose of this study was to assess the effect of preoperative physiotherapy (PT) on functional, subjective and socio-economic parameters after total knee arthroplasty (TKA).Methods20 patients (mean ± SD: age 67 ± 7 years) scheduled for TKA at Balgrist University Hospital between July 2016 and March 2017 were randomly assigned to a control (CG) or intervention (IG) group. 3 to 4 weeks prior to surgery the IG completed 5 to 9 sessions of PT containing proprioceptive neuromuscular facilitation (PNF) techniques, endurance training and individually indicated interventions. Measurements were executed at baseline, preoperative and 3 months after TKA. The primary outcome measure was the Stair Climbing Test (SCT), secondary outcome measures were the knee range of motion (ROM) and the level of physical activity using Lysholm Score (LS) and Tegner Activity Scale (TAS). The subjective and socio-economic parameters were the Patients' Global Impression of Change (PGIC) scale, inpatient rehabilitation time, preoperative pain levels and metabolic equivalent (MET), postoperative intake of analgesics and overall costs.ResultsNo difference between IG and CG was found for SCT (F (2/36) = 0.016, p = 0.984, η2 = 0.004). An interaction between group and time was shown for TAS (F (18/1) = 13.890) with an increase in the IG (p = 0.002, η2 = 0.536). The sub-item "pain" within the LS presented a higher pain-level in CG (F (18/1) = 4.490, p = 0.048, η2 = 0.974), while IG showed a higher preoperative MET compared to CG (p = 0.035). There were no other significant changes. The CG produced 21.4% higher overall costs, took more analgesics and showed higher preoperative pain levels than the IG.ConclusionsFindings show that preoperative therapy improved the level of physical activity before and after TKA and resulted in a clinically relevant gain in TAS.Trial registrationClinicalTrials.gov Identifier; NCT03160534. Registered 19 May 2017.

Project description:Interventions: Pre-operative exercise programme: The exercise programme will consist of 60 minutes individualised (one-to-one) training session with a registered physiotherapist, once a week, for 2 to 6 weeks (maximal of 6 sessions) before the patient undergoes their scheduled surgery. The last day of exercise will be the day before the patient undergoes surgery. The duration (2-6 weeks), specific exercises performed and intensity of the exercise programme will all be tailored to each patient through a health assessment, taking into consideration their current health status, physical activity level, co-morbidities and medical history. Each session will consist of 10 minutes of warm-up (walking and cycling), 40 minutes of aerobic and endurance exercises (such as cycling, treadmill and rower activity), respiratory and muscle strength exercises (breathing and weights training), and 10 minutes cool down (stretches and flexibility exercises). The aerobic and endurance exercises will be performed at 40% to 60% of the maximum heart rate and the strength training will be performed at an intensity of 40% to 60% of the one repetition maximum. Participant will be given instruction and recommendations on how to complete and progress these exercises (or similar exercises) at home (4 sessions x 60 minutes at home per week, up to the scheduled date of surgery). Furthermore, apart from the prescribed exercises, participants will be recommended to engage in moderate-intensity exercise for at least 150 minutes per week (such as walking or cycling). Home exercises will be captured in a daily exercise diary that participants will complete until the end of the exercise programme. Primary outcome(s): The feasibility of incorporating a standardised, intensive exercise programme into the pre-operative period for patients undergoing pelvic exenteration at Royal Prince Alfred Hospital. This will be determined by the number of eligible patients recruited, retention and adherence rates to the exercise programme. The retention rate will be defined as the percentage of individuals who completed the intervention. Adherence will be defined as the percentage of exercise sessions attended by those who were randomised to the intervention group. Adherence to the exercise programme will be recorded using attendance records (recorded by the study physiotherapist) / participant exercise diaries (recorded by the participant).[Feasibility will be assessed during the week before surgery (1 week pre-operative), ];The acceptability of incorporating a standardised, intensive exercise programme into the pre-operative period for patients undergoing pelvic exenteration at Royal Prince Alfred Hospital. This will be assessed by a semi structured questionnaire pre-discharge.[Acceptability will be assessed shortly before discharge after surgery (pre-hospital discharge).];The acceptability to patients of being randomised to the exercise program or usual care (satisfaction with study intervention). This will be determined by the number or eligible patients recruited to the trial (who accept being randomised to either treatment group), and by a semi structured questionnaire pre-discharge.[Acceptability of randomisation and patient satisfaction with the study intervention will be assessed at enrollment to the study and at pre-hospital discharge.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Dataset Information

Feasibility and acceptability of a preoperative exercise program for patients undergoing major cancer surgery: results from a pilot randomized controlled trial.

Objective

Design

Setting

Subjects

Methods

Results

Conclusions

Trial registration

Publications

Feasibility and acceptability of a preoperative exercise program for patients undergoing major cancer surgery: results from a pilot randomized controlled trial.

Similar Datasets

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