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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:BACKGROUND:The 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. METHODS:The 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. DISCUSSION:The 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 REGISTRATION:ClinicalTrials.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: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.

Project description:BackgroundThe human microbiota has a broad range of functions contributing to metabolic processes and the activities of our immune system. Its influence on health, well-being and chronic diseases are discussed in various studies. The intestinal microbiota and the mucosal integrity are influenced by diet, environment and other lifestyle factors, including physical activity. There are correlations between cardiorespiratory fitness and important markers of intestinal health. However, data linking endurance exercise to microbiota composition are sparse. Many endurance athletes take probiotics to reduce gastrointestinal symptoms linked to exercise or immunosuppression, but the longitudinal data is insufficient.This randomised, controlled cross-over pilot study will examine the impact of specific endurance training and probiotic supplementation on the intestinal microbiota and mucosa in healthy, athletic students.ObjectiveThe aim of this pilot study is to elucidate the impact of physical activity on the intestinal microbiota and mucosa with regard to the effects of a probiotic supplementation.MethodsIn this pilot study, thirty non-specifically trained student athletes will participate in an intervention consisting of a two-week rest (baseline) period, a four-week exercise programme and a four-week probiotic intervention using SymbioLactComp®. The exercise programme consists of three 60-min running workouts per week at 70-85% of the peak heart rate (HRpeak). Primary endpoint of this pilot study is the feasibility and practicality of the intervention as well as a sample size estimation. Furthermore, anthropometric measurements and information on nutrition and lifestyle will be obtained. The peak oxygen uptake (VO2peak) and peak heart rate (HRpeak) (determined during a shuttle run test) as well as selected blood and saliva parameters (haemogram, cytokines) will be evaluated. Changes to the intestinal microbiota will be analysed by stool diagnostics (KyberKompaktPRO®, KyberPlus®). The potential changes may include microbiota composition, bacterial metabolites and mucosa- and immune markers.ConclusionResults will be used for the design of a main randomised controlled trial with a larger collective based on feasibility, validity and sample size estimation as well as the potential effects of endurance exercise on intestinal microbiota and mucosa. Evidence-based information of an exercise-altered microbiota could be of importance for the prevention and therapy of intestinal or immune disorders.Trial registrationGerman Clinical Trials Register: DRKS00011108. Retrospectively registered on 28 November 2016.

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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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