Dataset Information

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy.

ABSTRACT:

Objective

Chemoradiotherapy (CRT) for head and neck cancer (HNC) is associated with high toxicity that adversely affects physical functioning, body composition, fatigue, quality of life and treatment outcomes. Exercise interventions during treatment might counteract these negative effects. We therefore assessed the feasibility of an exercise programme for HNC patients during CRT.

Methods

Forty patients were offered a tailored 10-week endurance and resistance training with supervised and home-based sessions. Feasibility endpoints were (1) adherence (main outcome): ≥60% attendance; (2) recruitment: ≥30%; (3) retention rate: ≥85% and (4) compliance rate: ≥60%. Physical performance, muscle strength, body composition, quality of life and fatigue were assessed pre- and post-intervention.

Results

Overall adherence was 54%. The recruitment rate was 36%, and the retention rate was 65%. Compliance to the supervised intervention protocol was 66%. Statistically significant decreases were found in mean grip strength, fat-free mass and clinically relevant deteriorations on several domains of quality of life, and fatigue subscales were found.

Conclusion

We conclude that this exercise programme for HNC patients during CRT in its current form is feasible for only a minority of patients. We suggest adaptations to improve adherence and retention rates for a definitive multicentre trial.

Trial registration

This study is registered at the Netherlands Trial Register (NTR7305), 6 June 2018, retrospectively registered.

SUBMITTER: Kok A

PROVIDER: S-EPMC9787293 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy.

Kok Annemieke A Passchier Ellen E May Anne M AM van den Brekel Michiel W M MWM Jager-Wittenaar Harriët H Veenhof Cindy C de Bree Remco R Stuiver Martijn M MM Speksnijder Caroline M CM

European journal of cancer care 20220811 6

<h4>Objective</h4>Chemoradiotherapy (CRT) for head and neck cancer (HNC) is associated with high toxicity that adversely affects physical functioning, body composition, fatigue, quality of life and treatment outcomes. Exercise interventions during treatment might counteract these negative effects. We therefore assessed the feasibility of an exercise programme for HNC patients during CRT.<h4>Methods</h4>Forty patients were offered a tailored 10-week endurance and resistance training with supervis ...[more]

PMID: 35953883

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Project description:PurposeTo evaluate the feasibility of a home-based moderate-to-vigorous intensity, phased (introduction, intermediate, maintenance), exercise prescription in breast cancer patients receiving cardiotoxic neoadjuvant chemotherapy.MethodsNineteen breast cancer patients were randomized to intervention or control for the duration of chemotherapy (16-24 weeks). The intervention was one aerobic exercise session at 80-90% VO2max for 25 min/week and 65%-75% VO2max for ≥ 50 min/week. Adherence to the tailored home-based program was assessed by heart rate monitors. Acceptability, tolerability, feasibility, efficacy, change in VO2max, and patient reported outcomes, safety, and clinical events were assessed.Results25.7% of eligible women consented (acceptability). Adherence was 87.6%. Women were not able to maintain exercise intensity as chemotherapy progressed (23.7% of exercise minutes were completed at prescribed heart rate during maintenance). Efficacy of the intervention was demonstrated by maintenance of VO2max (-1.0 ± 13.2%) compared to (-27.5 ± 7.4%) the control group. Further, during and after therapy, patients in the intervention arm reported less fatigue (control-baseline: 14.4 ± 15.9; midpoint: 19.0 ± 11.4; follow-up: 29.4 ± 20.0; intervention-baseline: 29.2 ± 24.6; midpoint: 24.6 ± 14.4; follow-up: 23.6 ± 11.9), impairment in activities (control-baseline: 13.7 ± 16.0; midpoint: 32.8 ± 17.0; follow-up: 58.6 ± 27.9; intervention-baseline: 38.7 ± 31.8; midpoint: 47.1 ± 27.5; follow-up: 47.5 ± 31.0), and pain (control-baseline: 80.8 ± 17.1; midpoint: 73.9 ± 20.7; follow-up: 50.7 ± 25.7; intervention-baseline: 68.7 ± 28.4; midpoint: 61.4 ± 22.5; follow-up: 65.3 ± 22.4). There were no differences in adverse events, treatment delays, or pathological complete response.ConclusionsNeoadjuvant breast cancer patients maintained approximately one hour/week of moderate-intensity exercise over the course of their treatment. Further, this volume of exercise was sufficient to maintain fitness capacity and quality of life compared to the control group.Trial registryClinicalTrials.gov Identifier: NCT03280836, prospectively registered 9/13/2017, https://clinicaltrials.gov/ct2/show/NCT03280836 .

Project description:IntroductionPatients with head and neck cancer (PwHNC) benefit from targeted exercise interventions: symptom relief, compensation for dysfunction, improvement in quality of life (QoL). Data on acceptance physical interventions in PwHNC are rare. The 'OSHO #94' trial investigates the short- and medium-term effects of individualized home exercise in PwHNC on QoL, physical activity and functionality. The study includes a feasibility phase (proof of concept) in order to evaluate the acceptance. Here we present the study protocol as well as the feasibility results.Methods and analysisThis prospective, multicentre, single-arm intervention study includes PwHNC ≥18 years of age in aftercare or palliative care with stable remission under immunotherapy. The study opened in January 01, 2021, with estimated completion by December 31, 2024. The PwHNC receive an individualized home exercise program consisting of mobilization, coordination, strengthening and stretching exercises. This should be carried out at least three times a week over 12 weeks for 15 to 30 minutes, supplemented by aerobic training two to three times a week for 30 minutes (intervention). Once weekly telephone calls with a physiotherapist are performed. Subsequently, there is a 12-week follow-up (FU) without exercise specifications/contact. Outcomes are measured before and after the intervention and following the FU. Primary outcome of the feasibility phase (n = 25) was the determination of the dropout rate during the intervention with a termination cut off if more than 30% PwHNC withdrew premature. The primary outcome of the OSHO #94' trial (N = 53) is the change in global QoL score from pre- to post-intervention (EORTC QLQ-C30). Secondary outcomes include clinical and patient-reported measures, training details as well as functional diagnostic data (e.g. level of physical activity, training frequency, flexibility, fall risk and aerobic performance).Results25 PwHNC were enrolled onto the feasibility cohort. Only16% (4/25 patients) did not complete the study. Therefore, recruitment of PwHNC was continued. The dropout rate was adjusted from 30% (N = 60) to 20% (N = 53, calculated sample size n = 42 PwHNC and 20% (n = 11) to dropout).ConclusionsIndividualized home exercise programs in PwHNC in aftercare seem feasible. Consequently, the aim is now to evaluate the short and medium-term effects of individualized home exercise.

Project description:Background contextChronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments.PurposeThis study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA.Study design/settingCost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed.Patient sampleA total of 241 older adults (≥65 years) with chronic mechanical neck pain comprised the patient sample.Outcome measuresThe outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon.MethodsThis work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates.ResultsTotal costs for SMT+HEA were 5% lower than HEA (mean difference: -$111; 95% confidence interval [CI] -$1,354 to $899) and 47% lower than SRE+HEA (mean difference: -$1,932; 95% CI -$2,796 to -$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained.ConclusionOn average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.

Project description:IntroductionNovel therapies for pulmonary hypertension (PH) have improved survival and slowed disease progression. However, patients still present with symptoms of exertional dyspnoea and fatigue, which impacts their ability to perform activities of daily living, reduces exercise tolerance and impairs their quality of life (QoL). Exercise training has shown to be safe and effective at enhancing QoL and physical function in PH patients, yet it remains an underused adjunct therapy. Most exercise training for PH patients has been offered through hospital-based programmes. Home-based exercise programmes provide an alternative model that has the potential to increase the availability and accessibility of exercise training as an adjunct therapy in PH. The purpose of this study is to investigate the feasibility, acceptability, utility and safety of a novel remotely supervised home-based PH exercise programme.MethodsSingle arm intervention with a pre/post comparisons design and a follow-up maintenance phase will be employed. Eligible participants (n=25) will be recruited from the Mater Misericordiae University Hospital PH Unit. Participants will undergo a 10-week home-based exercise programme, with induction training, support materials, telecommunication support and health coaching sessions followed by a 10-week maintenance phase. The primary outcomes are feasibility, acceptability, utility and safety of the intervention. Secondary outcomes will include the impact of the intervention on exercise capacity, physical activity, strength, health-related QoL and exercise self-efficacy.Ethics and disseminationEthics approval has been obtained from the Mater Misericordiae Institutional Review Board REF:1/378/2032 and Dublin City University Research Ethics DCUREC/2018/246. A manuscript of the results will be submitted to a peer-reviewed journal and results will be presented at conferences, community and consumer forums and hospital research conferences.Trial registration numberISRCTN83783446; Pre-results.

Project description:BackgroundMorbidity 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.ObjectiveIn 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.MethodsIn 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.ResultsRecruitment for this study began in January 2022 and is expected to be completed in the summer of 2023.ConclusionsResults 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 registrationClinicalTrials.gov NCT05496777; https://classic.clinicaltrials.gov/ct2/show/NCT05496777.International registered report identifier (irrid)DERR1-10.2196/46526.

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.

Dataset Information

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy.

Objective

Methods

Results

Conclusion

Trial registration

Publications

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy.

Similar Datasets

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