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Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study).

ABSTRACT: Hip fractures resulting from falls increase substantially with advancing age and less than half of older hip fracture survivors regain their former levels of mobility. There is increasing evidence that rehabilitation interventions with exercises that goes beyond the sub-acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care.A randomized controlled trial with blinded assessors and intention-to-treat analysis will be undertaken. We will recruit 82 older adults, 60 years or over who have suffered a hip fracture due to a fall in the previous 6 to 24 months. Participants randomized to the Intervention Group (IG) will undertake a physical exercise program involving progressive and challenging balance training and neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be taught to perform exercises at home, twice a week, using a booklet. Visits to monitor and progress the home exercise program will be conducted once a month, from the fourth to the sixth month and each 2 months until the end of the follow up at the 12th month, i.e., a total of 18 sessions. Participants will receive monthly phone calls to encourage exercise adherence. The control group will receive usual care. The primary outcome will be mobility-related disability and participants will be assessed at baseline, and at 3 months, 6 and 12 months. Participants will receive monthly phone calls to ask about falls and exercise adherence. Adverse effects will be monitored.This study proposes a home-based exercise program, which may in part overcome some barriers for rehabilitation, such as difficulties with public transportation and lack of a caregiver to accompany older patients to sessions. If a positive effect is observed this program has the potential to be incorporated into the public health system and contribute to building a pathway of care for older people with hip fracture.Clinicaltrials.gov Identifier: NCT02295527 .

SUBMITTER: Lima CA

PROVIDER: S-EPMC5126860 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study).

Lima Camila Astolphi CA Sherrington Catherine C Guaraldo Adriana A Moraes Suzana Albuquerque de SA Varanda Renata Dos Ramos RD Melo Juliana de Araújo JA Kojima Kodi Edson KE Perracini Monica M

BMC geriatrics 20161129 1

<h4>Background</h4>Hip fractures resulting from falls increase substantially with advancing age and less than half of older hip fracture survivors regain their former levels of mobility. There is increasing evidence that rehabilitation interventions with exercises that goes beyond the sub-acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if exercise program training for people who have suffered a fall-re ...[more]

PMID: 27894271

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Project description:BackgroundHip fractures are a common and serious consequence of osteoporosis, and hip fracture patients are at high risk for recurrence. Appropriate pharmacotherapy reduces this risk and is associated with reduced mortality after hip fracture, but a care gap exists for fracture prevention in these patients. This evaluation determined rates of osteoporosis treatment and bone mineral density (BMD) testing in hip fracture patients following discharge from a rehabilitation unit.MethodsA prospective cohort study of hip fracture patients aged ? 50 on an inpatient rehabilitation unit in 2008 and 2011. Patients were seen by a nurse specialist, and encouraged to see their family physician for further assessment and treatment. Physicians were sent a letter indicating the need to follow up with their patient. Patients were contacted following discharge from hospital to determine treatment rates.ResultsOf 310 eligible hip fracture patients admitted to the rehabilitation unit in the years studied, 207 patients were reached post-discharge and provided data. Of patients who were not previously taking osteoporosis medication, 59% of patients from the 2008 cohort, and 42% of patients from the 2011 cohort had osteoporosis treatment initiated by six months following discharge. By 2 months following discharge, 46% of patients in the 2008 cohort had a new BMD performed or scheduled, while this was true for 14% of patients from the 2011 cohort. 35% of patients in 2011 had not seen their family physician by 2 months following discharge.ConclusionsRates for osteoporosis treatment and BMD testing were higher than those reported in the literature for patients not enrolled in case manager programs. BMD testing declined from 2008 to 2011. Lower treatment rates may be due to concerns regarding reports of possible association between bisphosphonate use and atypical fractures. Improving rates of patient follow-up with family physicians will be important for increasing hip fracture treatment rates after discharge.

Project description:BackgroundA Rehabilitation Program for older adults with hip fracture (HIP-REP) based on Activity of Daily Living has been developed. The objectives of this study were to assess the feasibility and safety of the HIP-REP program to inform a future randomized controlled trial (RCT).MethodsA feasibility study Inspired by the Complex-intervention development (Medical Research Council framework phase II) design using quantitative and qualitative research methods were conducted. Eighteen participants (above 65 years) with hip fracture were recruited from the orthopedic wards. The setting was cross sectoral including Copenhagen University Hospital, Herlev and Gentofte and rehabilitation centers in Herlev, Gentofte and Lyngby-Taarbæk municipalities. A cross-sectoral rehabilitation intervention tailored to the needs of older adults with hip fracture highlighting systematic goal setting and strategies focused on activities of daily living was conducted. Pre-defined feasibility criteria: participants recruitment and retention, duration of measuring the outcome, adherence to intervention, and adverse events, along with self-reported outcomes and an objective measurement of performance in activity of daily living. Focus groups were analyzed using a deductive manifest content analysis approach. Descriptive statistical analysis and paired t-tests were performed for assessing change in outcome measures.ResultsRecruitment rate was 4.5/month. Outcome measures were performed but length and number of questionnaires were a burden. Thirteen out of eighteen participants completed the study three dropped out and two died. Adherence among the 13 was 100%. Focus group revealed issues regarding coordinating the intervention, ensuring procedural processes across sectors regarding recruitment of participants, and documentation in the database. Participants expressed satisfaction with the intervention and felt safe during intervention. Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability. No clear association between outcome improvements and intervention adherence.ConclusionsThe cross-sectoral intervention based on daily activities was feasible and safe for older adults with hip fracture. A future RCT, with an improved recruitment strategy and reduced number of outcome measures will evaluate the effectiveness in improving independence and safety performance of activity of daily living.Trial registrationClinicalTrials.gov ID: NCT03828240 . Registered on January 29, 2019.

Project description:ImportanceFor 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.ObjectiveTo determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended.Design, setting, and participantsRandomized 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.InterventionsThe 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.Main outcomes and measuresPhysical 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).ResultsAmong 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.Conclusions and relevanceAmong 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.Trial registrationclinicaltrials.gov Identifier: NCT00592813.

Project description:The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p<0.001) at posttest and 0.07 m/sec (95% CI: 0.02 to 0.12, p = 0.009) 12 months post surgery. The mean between-group QALY difference was -0.009 (95% CI: -0.061 to 0.038). The mean between-group total cost difference was +242.9 EUR (95% CI: -8397 to 8584). Our findings suggest that gait recovery after hip fracture can be improved by introducing a home-based balance and gait exercise program four months post surgery, without increasing total health care costs. Future research should focus on how to implement gait and balance exercise in comprehensive interventions that increase adherence among the most vulnerable persons and have an effect on daily life activities and patient-centred outcomes. Trial registration: ClinicalTrials.gov NCT01379456.

Project description:Introduction:Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. In particular ongoing exercise which targets balance can prevent up to 40% of falls. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population. Methods and analysis:The study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3?months (12?weeks) after discharge. The Primary outcome of the study is occurrence of falls. Falls will be measured at 3, 6, 12, and 24?months by research-assistant follow-up telephone calls for both the groups. Mobility-related disability will be measured with a self-reported test at every routine follow-up for up to two years using a performance-based short battery tool. Negative binomial regression model will be used to compare number of falls in both the groups by computing incidence ratio rates. Ethics and dissemination:Approval for the conduction of this study has been taken from the Ethical Review Committee (ERC) of the institution. Evidences which will be obtained from this study will facilitate to propose changes in existing guidelines and policies for treating fall and hip fracture patients.Trial registrationThis trial is registered on clinicaltrials.gov ID: NCT04108793.

Project description:There is limited evidence from 11 randomised controlled trials on the effect of rehabilitation interventions which incorporate outdoor mobility on ambulatory ability and/or self-efficacy after hip fracture. Outdoor mobility should be central (not peripheral) to future intervention studies targeting improvements in ambulatory ability.PurposeDetermine the extent to which outdoor mobility is incorporated into rehabilitation interventions after hip fracture. Synthesise the evidence for the effectiveness of these interventions on ambulatory ability and falls-related self-efficacy.MethodsSystematic search of MEDLINE, Embase, PsychInfo, CINAHL, PEDro and OpenGrey for published and unpublished randomised controlled trials (RCTs) of community-based rehabilitation interventions incorporating outdoor mobility after hip fracture from database inception to January 2021. Exclusion of protocols, pilot/feasibility studies, secondary analyses of RCTs, nonrandomised and non-English language studies. Duplicate screening for eligibility, risk of bias, and data extraction sample. Random effects meta-analysis. Statistical heterogeneity with inconsistency-value (I2).ResultsRCTs (n = 11) provided limited detail on target or achieved outdoor mobility intervention components. There was conflicting evidence from 2 RCTs for the effect on outdoor walking ability at 1-3 months (risk difference 0.19; 95% confidence intervals (CI): 0.21, 0.58; I2 = 92%), no effect on walking endurance at intervention end (standardised mean difference 0.05; 95% CI: - 0.26, 0.35; I2 = 36%); and suggestive (CI crosses null) of a small effect on self-efficacy at 1-3 months (standardised mean difference 0.25; 95% CI: - 0.29, 0.78; I2 = 87%) compared with routine care/sham intervention.ConclusionIt was not possible to attribute any benefit observed to an outdoor mobility intervention component due to poor reporting of target or achieved outdoor mobility and/or quality of the underlying evidence. Given the low proportion of patients recovering outdoor mobility after hip fracture, future research on interventions with outdoor mobility as a central component is warranted.Trial registrationPROSPERO registration: CRD42021236541.

Dataset Information

Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study).

Publications

Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study).

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