Effect of the Rehabilitation Program, ReStOre, on Serum Biomarkers in a Randomized Control Trial of Esophagogastric Cancer Survivors.
Ontology highlight
ABSTRACT: Background
The Rehabilitation Strategies Following Esophagogastric cancer (ReStOre) randomized control trial demonstrated a significant improvement in cardiorespiratory fitness of esophagogastric cancer survivors. This follow-up, exploratory study analyzed the biological effect of exercise intervention on levels of 55 serum proteins, encompassing mediators of angiogenesis, inflammation, and vascular injury, from participants on the ReStOre trial.Methods
Patients >6 months disease free from esophagogastric cancer were randomized to usual care or the 12-week ReStOre program (exercise training, dietary counselling, and multidisciplinary education). Serum was collected at baseline (T0), post-intervention (T1), and at 3-month follow up (T2). Serum biomarkers were quantified by enzyme-linked immunosorbent assay (ELISA).Results
Thirty-seven patients participated in this study; 17 in the control arm and 20 in the intervention arm. Exercise intervention resulted in significant alterations in the level of expression of serum IP-10 (mean difference (MD): 38.02 (95% CI: 0.69 to 75.35)), IL-27 (MD: 249.48 (95% CI: 22.43 to 476.53)), and the vascular injury biomarkers, ICAM-1 (MD: 1.05 (95% CI: 1.07 to 1.66)), and VCAM-1 (MD: 1.51 (95% CI: 1.04 to 2.14)) at T1. A significant increase in eotaxin-3 (MD: 2.59 (95% CI: 0.23 to 4.96)), IL-15 (MD: 0.27 (95% CI: 0 to 0.54)) and decrease in bFGF (MD: 1.62 (95% CI: -2.99 to 0.26)) expression was observed between control and intervention cohorts at T2 (p<0.05).Conclusions
Exercise intervention significantly altered the expression of a number of serum biomarkers in disease-free patients who had prior treatment for esophagogastric cancer.Impact
Exercise rehabilitation causes a significant biological effect on serum biomarkers in esophagogastric cancer survivors.Clinical trial registration
ClinicalTrials.gov (NCT03314311).
SUBMITTER: Kennedy SA
PROVIDER: S-EPMC8479183 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BACKGROUND:We previously found that autoantibodies against a panel of six tumor-associated antigens (p53, NY-ESO-1, MMP-7, Hsp70, PRDX6 and Bmi-1) may aid in early detection of esophageal squamous cell carcinoma. Here we aimed to evaluate the diagnostic value of this autoantibody panel in esophagogastric junction adenocarcinoma (EJA) patients. METHODS:Serum autoantibody levels were measured by enzyme-linked immunosorbent assay in a training cohort and a validation cohort. We used receiver-operating characteristics (ROC) to calculate diagnostic accuracy. RESULTS:We recruited 169 normal controls and 122 EJA patients to the training cohort, and 80 normal controls and 70 EJA patients to the validation cohort. Detection of the autoantibody panel demonstrated an area under the curve (AUC) of 0.818, sensitivity 59.0% and specificity 90.5% in training cohort, and AUC 0.815, sensitivity 61.4% and specificity 90.0% in validation cohort in the diagnosis of EJA. Measurement of the autoantibody panel could distinguish early stage EJA patients from normal controls (AUC 0.786 and 0.786, sensitivity 50.0% and 56.0%, and specificity 90.5% and 90.0%, for training and validation cohorts, respectively). Moreover, a restricted panel consisting of autoantibodies against p53, NY-ESO-1 and Bmi-1 exhibited similar diagnostic performance for EJA (AUC 0.814 and 0.823, sensitivity 53.5% and 60.0%, and specificity 90.5% and 93.7%, for training and validation cohorts, respectively) and early stage EJA (AUC 0.744 and 0.773, sensitivity 55.6% and 52.0%, and specificity 90.5% and 93.7%, for training and validation cohorts, respectively). CONCLUSIONS:Autoantibodies against an optimized TAA panel as serum biomarkers appear to help identify the present of early stage EJA.
| S-EPMC6476828 | biostudies-literature
Project description:Head and neck cancer survivors frequently experience nutritional challenges, and proper rehabilitation should be offered. The trial objective was to test the effect of a multidisciplinary residential nutritional rehabilitation programme addressing physical, psychological, and social aspects of eating problems after treatment. In a randomized controlled trial, 71 head and neck cancer survivors recruited through a nationwide survey were randomized to the program or a wait-list control group. Inclusion was based on self-reported interest in participation. The primary outcome was change in body weight. Secondary outcomes included physical function, quality of life, and symptoms of anxiety and depression. Differences between groups at the 3-month follow-up were tested. No significant differences were seen in body weight change, but there were overall trends towards greater improvements in physical function (hand grip strength: p = 0.042; maximal mouth opening: p = 0.072) and quality of life ("Role functioning": p = 0.041; "Speech problems": p = 0.040; "Pain": p = 0.048) in the intervention group. To conclude, a multidisciplinary residential nutritional rehabilitation program had no effect on body weight in head and neck cancer survivors with self-reported interest in participation, but it may have effect on physical function and quality of life. Further research on relevant outcomes, inclusion criteria, and the program's effect in different subgroups is needed.
| S-EPMC7400860 | biostudies-literature
Project description:Despite proven efficacy of cardiac rehabilitation (CR) in reducing the all-cause mortality in patients after myocardial revascularization, the penetration of CR, due to patient-related factors and referral rates remains limited. To improve the outcomes, home-based tele-rehabilitation (TR) has been proposed recently. In theory TR enhances the effects of standard CR procedures due to implementation of an intelligent monitoring system designed to ensure optimal training through on-demand transmission of vital signs, aimed at motivating the patients through daily schedule reminders, setting daily goals and creating a platform for mutual feedback. Several meta-analyses assessing various studies comparing these two methods (CR and TR) have proven that they are at least equally effective, with some of the research showing superiority of TR. Although there was a small sample size, lack of long-term follow-up, reporting effects of TR itself, no integration with tools designed for coaching, motivating and promoting a healthy lifestyle constitutes an important limitation. The latter carries a hopeful prognosis for improvement when utilizing a broad-spectrum approach, especially with use of dedicated technological solutions exploiting the fact of a large and yet rapidly increasing penetration of smartphones, mobile PCs and tablets in the population. The above-mentioned findings worked as the basis and rationale for commencing the RESTORE project aimed at developing and delivering state-of-the-art, comprehensive TR for patients after myocardial revascularization and evaluating its molecular aspect in view of how it influences the atherosclerosis progression attenuation. This paper presents the current state and rationale behind the project based on up-to-date TR efficacy data.
| S-EPMC8084403 | biostudies-literature
Project description:(1) To assess the efficacy of a specific rehabilitation protocol for femoroacetabular impingement syndrome (FAIS), patients who underwent hip arthroscopy (HA) were compared with a control group. (2) Patients with symptomatic FAIS who were scheduled for HA were randomized either to a control group (n = 45, 66.6% men, 41.8 ± 12.4 years) following a general post-surgical treatment protocol or to an experimental group (n = 45, 71.2% men, 40.9 ± 7.6 years) following a specific rehabilitation protocol supervised by a physiotherapist. Range of motion (ROM), orthopedic tests and pain were assessed immediately before surgery and at 4 and 14 weeks after surgery. The hip functional status was assessed by the modified Harris Hip Score (mHHS) before surgery and at the end of follow-up. (3) At 14 weeks after surgery and compared with the control group, the experimental group showed a lower percentage of positives for hip provocation tests (15.6% vs. 46.6% on Faber test; 15.6% vs. 77.8% on Fadir test; 2.2% vs. 20% on Ober test, experimental vs. control group, p < 0.001), a greater improvement in mHHS (27.2 vs. 10.7 points, p < 0.001) and higher ROM for all the movements evaluated: flexion (99.6 ± 12.2 vs. 89.6 ± 4.5, p < 0.001), extension (20.6 ± 5.8 vs. 13.3 ± 2.6, p < 0.001), adduction (30.6 ± 5.7 vs. 23.4 ± 8.4, p < 0.001), abduction (43.4 ± 10.7 vs. 32.8 ± 8.4, p < 0.001) and both internal (28.2 ± 8.5 vs. 18.7 ± 6.1, p < 0.001) and external hip rotation (36.8 ± 9.3 vs. 27.4 ± 5.6. p < 0.001). The pain decreased after surgery for both groups, although the reduction was greater in the experimental group at the end of intervention (13.8 ± 16.1 vs. 34.9 ± 16.3 mm, experimental vs. control group, p < 0.001). (4) The specific and supervised rehabilitation program in patients with FAIS undergoing HA showed better benefits at 14 weeks of treatment than the benefits achieved by a care protocol in terms of pain reduction and recovery of hip motion.
| S-EPMC8307353 | biostudies-literature
Project description:BackgroundCurative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver.MethodsThe ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed.DiscussionThis RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors.Trial registrationThe study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.
| S-EPMC7222585 | biostudies-literature
Project description:BackgroundKnowledge of clinically established factors of physical function such as body composition, bioelectrical phase angle (PhA) and handgrip strength (HGS) with mortality predictive and health-related relevance is limited in prostate cancer survivors (PCS). Therefore, the aim of this study was to characterise and compare body composition data of PCS with extensive reference data as well as to analyse PhA and HGS and the prevalence of critical prognostic values at an early stage of cancer survivorship.MethodsOne hundred and forty-eight PCS were examined at the start (T1) and end (T2) of a 3-week hospitalised urooncological rehabilitation, which began median 28 days after acute cancer therapy. Examinations included a bioimpedance analysis and HGS test. Comparison of body composition between PCS and reference data was performed using bioimpedance vector analysis (BIVA).ResultsBIVA of the whole PCS group showed abnormal physiology with a cachectic state and a state of overhydration/oedema, without significant changes between T1 and T2. The age- and BMI-stratified subgroup analysis showed that PCS aged 60 years and older had this abnormal pattern compared to the reference population. HGS (T1: 38.7 ± 8.9 vs T2: 40.8 ± 9.4, kg), but not PhA (T1/T2: 5.2 ± 0.7, °), changed significantly between T1 and T2. Values below a critical threshold reflecting a potentially higher risk of mortality and impaired function were found for PhA in 20% (T1) and 22% (T2) of PCS and in 41% (T1) and 29% (T2) for HGS.ConclusionsBIVA pattern and the prevalence of critically low HGS and PhA values illustrate the necessity for intensive continuation of rehabilitation and survivorship care especially in these 'at risk' cases. The routine assessment of body composition, PhA and HGS offer the opportunity to conduct a risk stratification for PCS and could help personalising and optimising treatment in rehabilitation and ongoing survivorship care.
| S-EPMC8689438 | biostudies-literature
Project description:For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established.To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended.Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture.The intervention group (n?=?120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n?=?112) received in-home and telephone-based cardiovascular nutrition education.Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function).Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P?<?.001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58.1 [SD, 7.9] at 6 months; control group: 56 [SD, 7.1] at baseline, 56.6 [SD, 8.1] at 6 months; and between-group difference, 1.3 [95% CI, 0.2 to 2.4], P?=?.03; and mean AM-PAC daily activity scores for intervention group: 57.4 [SD, 13.7] at baseline, 61.3 [SD, 15.7] at 6 months; control group: 58.2 [SD, 15.2] at baseline, 58.6 [SD, 15.3] at 6 months; and between-group difference, 3.5 [95% CI, 0.9 to 6.0], P?=?.03). In multiple imputation analyses, between-group differences remained significant for SPPB and AM-PAC daily activity, but not for mobility. Significant between-group differences persisted at 9 months for all functional measures with and without imputation.Among patients who had completed standard rehabilitation after hip fracture, the use of a home-based functionally oriented exercise program resulted in modest improvement in physical function at 6 months after randomization. The clinical importance of these findings remains to be determined.clinicaltrials.gov Identifier: NCT00592813.
| S-EPMC4454368 | biostudies-literature
Project description:ImportanceClinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits.ObjectiveTo compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation.Design, setting, and participantsPhase 3, pragmatic, single-blind randomized trial among 361 participants with moderate motor impairment recruited from 7 US hospitals over 44 months, treated in the outpatient setting from June 2009 to March 2014.InterventionsStructured, task-oriented upper extremity training (Accelerated Skill Acquisition Program [ASAP]; n = 119); dose-equivalent occupational therapy (DEUCC; n = 120); or monitoring-only occupational therapy (UCC; n = 122). The DEUCC group was prescribed 30 one-hour sessions over 10 weeks; the UCC group was only monitored, without specification of dose.Main outcomes and measuresThe primary outcome was 12-month change in log-transformed Wolf Motor Function Test time score (WMFT, consisting of a mean of 15 timed arm movements and hand dexterity tasks). Secondary outcomes were change in WMFT time score (minimal clinically important difference [MCID] = 19 seconds) and proportion of patients improving ≥25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points).ResultsAmong the 361 randomized patients (mean age, 60.7 years; 56% men; 42% African American; mean time since stroke onset, 46 days), 304 (84%) completed the 12-month primary outcome assessment; in intention-to-treat analysis, mean group change scores (log WMFT, baseline to 12 months) were, for the ASAP group, 2.2 to 1.4 (difference, 0.82); DEUCC group, 2.0 to 1.2 (difference, 0.84); and UCC group, 2.1 to 1.4 (difference, 0.75), with no significant between-group differences (ASAP vs DEUCC: 0.14; 95% CI, -0.05 to 0.33; P = .16; ASAP vs UCC: -0.01; 95% CI, -0.22 to 0.21; P = .94; and DEUCC vs UCC: -0.14; 95% CI, -0.32 to 0.05; P = .15). Secondary outcomes for the ASAP group were WMFT change score, -8.8 seconds, and improved SIS, 73%; DEUCC group, WMFT, -8.1 seconds, and SIS, 72%; and UCC group, WMFT, -7.2 seconds, and SIS, 69%, with no significant pairwise between-group differences (ASAP vs DEUCC: WMFT, 1.8 seconds; 95% CI, -0.8 to 4.5 seconds; P = .18; improved SIS, 1%; 95% CI, -12% to 13%; P = .54; ASAP vs UCC: WMFT, -0.6 seconds, 95% CI, -3.8 to 2.6 seconds; P = .72; improved SIS, 4%; 95% CI, -9% to 16%; P = .48; and DEUCC vs UCC: WMFT, -2.1 seconds; 95% CI, -4.5 to 0.3 seconds; P = .08; improved SIS, 3%; 95% CI, -9% to 15%; P = .22). A total of 168 serious adverse events occurred in 109 participants, resulting in 8 patients withdrawing from the study.Conclusions and relevanceAmong patients with motor stroke and primarily moderate upper extremity impairment, use of a structured, task-oriented rehabilitation program did not significantly improve motor function or recovery beyond either an equivalent or a lower dose of UCC upper extremity rehabilitation. These findings do not support superiority of this program among patients with motor stroke and primarily moderate upper extremity impairment.Trial registrationclinicaltrials.gov Identifier: NCT00871715.
| S-EPMC4795962 | biostudies-literature
Project description:Background: Exercise rehabilitation programmes, traditionally involving supervised exercise sessions, have had to rapidly adapt to virtual delivery in response to the coronavirus disease 2019 (COVID-19) pandemic to minimise patient contacts. In the absence of an effective vaccine, the pandemic is likely to persist in the medium term and during this time it is important that the feasibility and effectiveness of remote solutions is considered. We have previously established the feasibility of the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) intervention - a face to face multidisciplinary rehabilitation programme for upper gastrointestinal (UGI) cancer survivors. This study will examine the feasibility of a virtually delivered 12-week multi-component ReStOre@Home programme. Methods: This single arm feasibility study will recruit 12 patients who have completed curative treatment for oesophago-gastric cancer. Participants will complete the 12-week ReStOre@Home programme consisting of exercise (aerobic and resistance training), 1:1 dietary counselling and group education sessions through virtual delivery. Underpinned by the Medical Research Council (MRC) Framework, feasibility will be determined by recruitment rates, adherence, retention, incidents, and acceptability. Acceptability will be assessed qualitatively through post-intervention interview and the Telehealth Usability Questionnaire. Secondary outcomes will be assessed pre and post-intervention and will include measures of physical performance (cardiopulmonary exercise test, short physical performance battery, hand grip strength, Godin Leisure Time Questionnaire, and body composition), health related quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) and oesophago-gastric cancer specific subscale (EORTC-QLQ-OG25), fatigue (Multidimensional Fatigue Inventory (MFI-20), and venous blood samples will be collected for the UGI Cancer Survivorship Biobank. Discussion: The ReStOre@Home feasibility study will provide important data regarding the amenability of a multidisciplinary programme designed for UGI cancer survivors to virtual delivery. Trial registration: ClinicalTrials.gov NCT04603339 (26/10/2020).
| S-EPMC8127012 | biostudies-literature
Project description:ObjectiveTo compare the effects of a home-based pulmonary rehabilitation (PR) program with and without telecoaching on health-related outcomes in COVID-19 survivors.MethodsA total of 42 COVID-19 patients who completed medical treatment were randomly divided into two groups: the study (telecoaching) group (n = 21) and the control (no telecoaching) group (n = 21). Both groups participated in an 8-week home-based PR program including education, breathing exercises, strength training, and regular walking. The study group received phone calls from a physiotherapist once a week. Both groups of patients were assessed before and after the program by means of the following: pulmonary function tests; the modified Medical Research Council dyspnea scale; the six-minute walk test; extremity muscle strength measurement; the Saint George's Respiratory Questionnaire (to assess disease-related quality of life); the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36, to assess overall quality of life); and the Hospital Anxiety and Depression Scale.ResultsIn both groups, there were significant improvements in the following: FVC; the six-minute walk distance; right and left deltoid muscle strength; Saint George's Respiratory Questionnaire activity domain, impact domain, and total scores; and SF-36 social functioning, role-physical, role-emotional, and bodily pain domain scores (p < 0.05). Decreases in daily-life dyspnea, exertional dyspnea, and exertional fatigue were significant in the study group (p < 0.05), and the improvement in SF-36 social functioning domain scores was greater in the study group (p < 0.05).ConclusionsA home-based PR program with telecoaching increases social functioning and decreases daily-life dyspnea, exertional dyspnea, and exertional fatigue in COVID-19 survivors in comparison with a home-based PR program without telecoaching.
| S-EPMC9970366 | biostudies-literature