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The EXPRESS Study: Exercise and Protein Effectiveness Supplementation Study supporting autonomy in community dwelling frail older people-study protocol for a randomized controlled pilot and feasibility study.

ABSTRACT: Research has repeatedly demonstrated that exercise has a positive impact on physical function and is beneficial in the treatment of physical frailty. However, an even more effective strategy for managing physical frailty might be the combination of multicomponent exercise with the intake of high-quality protein supplements, but the efficacy remains unclear for older adults who are already pre-frail and frail. The aim is to examine the feasibility of recruiting frail older adults to participate in a trial designed to determine the potential effects of a 6-month exercise and nutrition intervention on physical function. The feasibility objectives will include frail older peoples' compliance, the safety and tolerability of the trial, the estimation of estimates to aid sample size calculation, and the potential efficacy. Primary outcomes for the main trial will include gait speed, grip strength and physical performance. Secondary outcomes will include frailty status, muscle mass, nutritional intake, physical activity levels, cognitive performance and quality of life.A randomised, parallel, control pilot and feasibility study will be conducted. All participants will be randomly assigned to either (a) an exercise program + high-quality protein supplement or (b) an exercise program + low-quality protein supplement. Both protein supplements will be matched closely in colour, flavour and packaging so that both the participants and the research staff are blinded. The exercise program will be the same in both groups. Assessments will be conducted at baseline and at 3 and 6 months and include gait speed, grip strength, the Short Physical Performance Battery, Timed Up and Go Test, FRAIL Screen, bioelectrical impedance analyses, 24-h dietary recall, Katz Activities of Daily Living, Lawton Instrumental Activities of Daily Living, the Trail Making Test, Short Form Health Survey-36, and 1 week accelerometer quantification. The data will be analysed using an ANCOVA model.This study is expected to provide much needed insight into the feasibility of recruiting and retaining frail older adults into community-based intervention programs, while providing knowledge relating to the safety, tolerability and benefits of a combined exercise and protein supplement program designed to halt or reverse the transition of physical frailty in the community. If shown to be effective, this strategy could be included in the best practice clinical guidelines for community-dwelling older adults who are pre-frail or frail.Australian New Zealand Clinical Trials Registry, ACTRN12616000521426.

SUBMITTER: Jadczak AD

PROVIDER: S-EPMC5500992 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Project description:ObjectivesTo determine whether combining behavioral urinary incontinence (UI) treatments with physical activity improves UI in frail older women.DesignSingle-blind, two-arm pilot randomized controlled trial.SettingSenior apartments.ParticipantsFrail women (mean age 84.9 ± 6.4) without dementia (n = 42).InterventionTwelve-week program of customized behavioral UI treatments: 150 minutes of weekly walking and twice weekly strength training classes.MeasurementsUI was measured using 3-day bladder diaries, the International Consultation on Incontinence Questionnaire (ICIQ), and UI global improvement questions. Toileting skills were measured using the Performance Oriented Timed Toileting Instrument (POTTI) and the Minnesota Toileting Skills Questionnaire (MTSQ). Physical function was measured using the Short Physical Performance Battery. UI-related quality of life was measured using the Incontinence Impact Questionnaire and Urogenital Distress Inventory.ResultsThe treatment group reported a 50% reduction in daily leaks using bladder diaries, and the control group reported no change (P = .04). Although there were no group differences in total ICIQ scores (P = .66), the treatment group reported significantly greater improvement on the ICIQ item for urine leakage (P = .01). More than 81% of the treatment group and 36% of the control group reported improvement in UI (χ2 = 4.84, P = .01), with mean estimated percentage improvement of 65.3 ± 32.0 versus 34.1 ± 41.3 (P = .03). Although the difference was not statistically significant, treatment group participants improved their toileting skills, whereas those of the control group declined (P = .42 POTTI, P = .11 MTSQ). Balance (P = .33) and gait (P = .24) improved more in the treatment group, whereas chair stands improved more in the control group (P = .14).ConclusionUI may be improved in frail older women by combining behavioral strategies for UI with physical activity, but larger trails are needed to determine whether these findings can be replicated and sustained.

Project description:BackgroundDespite the clear benefits of physical activity in healthy ageing, engagement in regular physical activity among community-dwelling older adults remains low, with common barriers including exertional discomfort, concerns with falling, and access difficulties. The recent rise of the use of technology and the internet among older adults presents an opportunity to engage with older people online to promote increased physical activity. This study aims to determine the feasibility and acceptability of training volunteers to deliver online group exercises for older adults attending community social clubs.MethodsThis was a pre-post mixed-methods study. Older adults aged ≥ 65 years attending community social clubs who provided written consent and were not actively participating in exercise classes took part in the feasibility study. Older adults, volunteers, and staff were interviewed to determine the acceptability of the intervention. The intervention was a once weekly volunteer-led online group seated strength exercises using resistance bands. The duration of the intervention was 6 months. The primary outcome measures were the feasibility of the intervention (determined by the number of volunteers recruited, trained, and retained, participant recruitment and intervention adherence) and its acceptability to key stakeholders. Secondary outcome measures included physical activity levels (Community Health Model Activities Programme for Seniors (CHAMPS) questionnaire), modified Barthel Index, Health-related quality of life (EQ-5D-5L), frailty (PRISMA-7) and sarcopenia (SARC-F), at baseline and 6 months.ResultsNineteen volunteers were recruited, 15 (78.9%) completed training and 9 (47.3%) were retained after 1 year (mean age 68 years). Thirty older adults (mean age 77 years, 27 female) participated, attending 54% (IQR 37-67) of exercise sessions. Participants had no significant changes in secondary outcome measures, with a trend towards improvement in physical activity levels (physical activity in minutes per week at baseline was 1770 min, and 1909 min at six months, p = 0.13). Twenty volunteers, older adults, and staff were interviewed and found the intervention acceptable. The seated exercises were perceived as safe, manageable, and enjoyable.ConclusionsTrained volunteers can safely deliver online group exercise for community-dwelling older adults which was acceptable to older adults, volunteers, and club staff.Trials registrationNCT04672200.

Project description:BackgroundThe proportion of older citizens is increasing worldwide. A well-known syndrome in old age is physical frailty which is associated with a greater risk of disabilities in activities of daily living, greater reliance on in-home services, hospitalization, institutionalization, and premature mortality. The purpose of this study is to determine the effects of an intervention with high-protein diet alone or in combination with power training in pre-frail and frail old adults.MethodsThe study is a community-based assessor-blinded parallel randomized controlled trial (RCT), consisting of two phases. Phase 1 is a 1-month stabilization phase, where self-reliant community-dwelling adults + 80 years old will receive individual guidance regarding protein intake, to prevent the risk of negative protein balance prior to phase 2 and to only include participants who have reached the minimum recommended level of protein intake (1.0 g/kg/day) in the randomized controlled trial. Phase 2 is a 4-month RCT where 150 participants will be randomized into the following three arms: protein-only where participants will be provided with dairy products to increase their protein intake to 1.5 g/kg/day, protein + exercise where participants will be provided with the protein intervention in combination with power training two times a week, and recommendation group where participants will continue as in phase 1. Primary outcome is lower leg muscle power. Secondary outcomes include physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life. The statistical analysis will include an intention-to-treat analysis of all randomized participant and per-protocol analysis of all compliant participants. The study hypothesis will be tested with mixed linear models to assess changes in the main outcomes over time and between study arms.DiscussionThe finding of this study may add to the knowledge about the beneficial effects of high-protein diet from dairy products combined with power training to counteract frailty in community-dwelling older adults. This may ultimately have an impact on the ability to live well and independent for longer.Trial registrationClinicalTrials.gov NCT03842579 . Registered on 15 February 2019, version 1.

Project description:IntroductionFrailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD.Methods and analysisThe EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2).Ethics and disseminationEthical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body.Trial registration numberISRCTN87708989.

Project description:Whole-body electromyostimulation (WB-EMS) induces high-intense stimuli to skeletal muscles with low strain on joints and the autonomic nervous system and may thus be suitable for frail, older people. However, if trained at very high intensities, WB-EMS may damage muscles and kidneys (rhabdomyolysis). This study aimed at investigating the feasibility, safety and preliminary efficacy of WB-EMS in frail, older people. Seven frail (81.3 ± 3.5 years), 11 robust (79.5 ± 3.6 years), 10 young (29.1 ± 6.4 years) participants completed an eight-week WB-EMS training (week 1-4: 1x/week; week 5-8: 1.5x/week) consisting of functional exercises addressing lower extremity strength and balance. Feasibility was assessed using recruitment, adherence, retention, and dropout rates. The satisfaction with WB-EMS was measured using the Physical Activity Enjoyment Scale for older adults (PACES-8). In week 1, 3, and 8 creatine kinase (CK) was assessed immediately before, 48 and 72 h after WB-EMS. Symptoms of rhabdomyolysis (muscle pain, muscle weakness, myoglobinuria) and adverse events were recorded. Functional capacity was assessed at baseline and after 8 weeks using the Short Physical Performance Battery (SPPB), Timed Up-and-Go Test (TUG), Choice Stepping Reaction Time Test (CSRT), 30-second Chair-Stand Test (30-STS), maximum isometric leg strength and handgrip strength. The recruitment rate of frail individuals was 46.2%, adherence 88.3% and the dropout rate 16.7%. All groups indicated a high satisfaction with WB-EMS. CK activity was more pronounced in young individuals with significant changes over time. Within older people CK increased borderline-significantly in the frail group from baseline to week 1 but not afterwards. In robust individuals CK increased significantly from baseline to week 1 and 3. No participant reached CK elevations close to the threshold of ≥5,000 U/l and no symptoms of rhabdomyolysis were observed. With the exception of the TUG (p = 0.173), frail individuals improved in all tests of functional capacity. Compared to the young and robust groups, frail individuals showed the greater improvements in the SPPB, handgrip strength, maximum isokinetic hip-/knee extension and flexion strength. WB-EMS is feasible for frail older people. There were no clinical signs of exertional rhabdomyolysis. WB-EMS proved to be sufficiently intense to induce meaningful changes in functional capacity with frail individuals showing greater improvements for several measures.

Project description:BackgroundEffective multicomponent interventions in the community targeted at preventing frailty in at-risk older adults can promote healthy ageing. However, there is a lack of studies exploring the effectiveness of technology-enabled autonomous multi-domain community-based interventions for frailty. We developed a novel end-to-end System for Assessment and Intervention of Frailty (SAIF) with exercise, nutrition, and polypharmacy components. This pilot study aimed to explore SAIF's effectiveness in improving frailty status, physical performance and strength, and its usability in pre-frail older adults.Materials and methodsThis is a single arm 8-week pilot study in 20 community-dwelling older adults who were pre-frail, defined using the Clinical Frailty Scale (CFS) as CFS 3 + (CFS 3 and FRAIL positive) or CFS 4. For outcomes, we assessed frailty status using the modified Fried Frailty Phenotype (FFP) and CFS; physical performance using Short Physical Performance Battery (SPPB); and Hand Grip Strength (HGS) at baseline and 8-week. User experience was explored using the System Usability Scale (SUS), interest-enjoyment subscale of the Intrinsic Motivation Inventory and open-ended questions. We analyzed effectiveness using repeated-measures tests on pre-post scores, and usability using a convergent mixed-method approach via thematic analysis of open-ended responses and descriptive statistics of usability/interest-enjoyment scales.ResultsSixteen participants (71.8 ± 5.5 years) completed the 8-week study. There was a significant improvement in FFP score (-0.5, p < 0.05, effect size, r = 0.43), but not CFS (-1.0, p = 0.10, r = 0.29). Five (31.3%) improved in frailty status for both FFP and CFS. SPPB (+1.0, p < 0.05, r = 0.42) and HGS (+3.5, p < 0.05, r = 0.45) showed significant improvements. Three themes were identified: "Difficulty in module navigation" (barriers for SAIF interaction); "User engagement by gamification" (facilitators that encourage participation); and "Perceived benefits to physical health" (subjective improvements in physical well-being), which corroborated with SUS (68/100) and interest-enjoyment (3.9/5.0) scores. Taken together, user experience results cohere with the Senior Technology Acceptance and Adoption Model.ConclusionOur pilot study provides preliminary evidence of the effectiveness of SAIF in improving frailty status, physical performance and strength of pre-frail older adults, and offers user experience insights to plan the follow-up large-scale randomized controlled trial.

Project description:PurposeSarcopenia is a poor prognostic factor in cancer patients, and exercise is one of the treatments to improve sarcopenia. However, there is currently insufficient evidence on whether exercise can improve sarcopenia in patients with advanced cancers. This study examined the feasibility of exercise in advanced gastrointestinal (GI) cancer patients treated with palliative chemotherapy.MethodsBetween 2020 and 2021, 30 patients were enrolled in a resistance and aerobic exercise program for six weeks. The exercise intervention program (EIP) consisted of low, moderate, and high intensity levels. Patients were asked to select the intensity level according to their ability. The primary endpoint was the feasibility of the EIP measured by compliance during the six weeks. A compliance of over 50% was considered acceptable. The secondary endpoints were changes in weight and muscle mass, safety, quality of life (QoL) and overall survival (OS).ResultsThe median age of the study's participants was 60 (30-77). The total compliance to the EIP was 63.3% (19/30 patients). Sixteen (53.3%) patients had a compliance of over 80%. The attrition rate was 30.0% (9/30). The mean exercise time was 41.4 min, and the aerobic exercise was 92.3% and the resistant exercise was 73.7%, and both exercise was 66.5%. Most patients performed the moderate intensity level exercises at home or near their home. The mean skeletal muscle index (SMI) was 43.5 cm2/m2 pre-chemotherapy and 42.2 cm2/m2 after six weeks of chemotherapy, with a decrease of -1.2 ± 2.8 cm2/m2 (-3.0%) (p = 0.030). In the poor compliance group, the mean SMI decrease was -2.8 ± 3.0 cm2/m2 which was significantly different (p = 0.033); however, in the good compliance group, the mean SMI decrease was -0.5 ± 2.5 cm2/m2 which was maintained over the six weeks (p = 0.337). The good compliance group had a significantly longer median OS compared with the poor compliance group (25.3 months vs. 7.9 months, HR = 0.306, 95% CI = 0.120-0.784, p = 0.014). The QoL showed a better score for insomnia (p = 0.042). There were no serious adverse events.ConclusionsThe EIP during palliative chemotherapy in advanced GI cancer patients showed good compliance. In the good compliance group, muscle mass and physical functions were maintained for six weeks. The EIP was safe, and the QoL was maintained. Based on this study, further research in exercise intervention in advanced cancer patients is needed.Clinical trial registrationThe clinical trial registration number is KCT 0005615 (CRIS, https://cris.nih.go.kr/cris/en/ ); registration date, 23rd Nov 2020.

Project description:BackgroundAging is associated with progressive loss of musculoskeletal performance. Exercise interventions can improve physical function in the elderly but there is a paucity of comparative assessments in order to understand what specific goals can be achieved particularly with less demanding exercise interventions readily accessible for untrained men.MethodsProspective randomized, controlled, single center exploratory trial to compare four distinct exercise interventions, i.e. Resistance Training (RT), Whole Body Vibration Exercise (WBV), Qi Gong (QG) and wearing a Spinal orthosis (SO) for 6 months in men at risk for osteoporosis aged 65-90 years. Primary endpoint was change in isometric one repetition maximum force trunk strength for extension (TSE) and flexion (TSF) compared to baseline, secondary endpoints covered key parameters of geriatric functional assessment, including Handgrip Strength (HS), Chair-Rise-Test (CRT), Usual Gait Speed (UGS) and Timed-Up-and-Go (TUG).ResultsAltogether 47 men (mean age 77 ±6.1 years) were randomized to RT, (n = 11) WBV (n = 13), QG (n = 10) and SO(n = 13). RT, defined as reference exercise intervention, lead to significant improvements for TSE (p = 0.009) and TSF (p = 0.013) and was significantly superior in the between-group analysis for TSE (p = 0.038). Vibration exercise caused sign. Improvements in TSE (p = 0.014) and CRT (p = 0.005), the Spinal orthosis improved CRT (p = 0.003) and Gait Speed (p = 0.027), while the QG intervention did not attain any sig. Developments.Subgroup analyses revealed most pronounced musculoskeletal progress in vulnerable patients (age ≥ 80 years, pre-sarcopenia, multimorbidity ≥3chronic diseases). Irrespective of the type of exercise, participants ≥80 years experienced significant gains in TSE (p = 0.029) and CRT (p = 0.017). Presarcopenic subjects (Skeletal muscle Index (SMI) ≤10.75 kg/m2) improved in TSE (p = 0.003), CRT (p = 0.001) and UGS (p = 0.016). Multimorbid participants achieved sig. Gains in TSE (p < 0.001), TSF (p = 0.002), UGS (p = 0.036) and HS (p = 0.046).ConclusionsIn this exploratory trial we found that simple exercise interventions are feasible in elderly men eliciting specific benefits, i.e. improvements are attained in those tasks addressed with the respective exercise modality. While targeted resistance training is superior in increasing TSE, alternative simple exercise interventions also appear to elicit beneficial effects, even in vulnerable patients, i.e. those with low muscle mass, above 80 years of age or multimorbidity.

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The EXPRESS Study: Exercise and Protein Effectiveness Supplementation Study supporting autonomy in community dwelling frail older people-study protocol for a randomized controlled pilot and feasibility study.

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