Dataset Information

The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.

ABSTRACT:

Background

Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures.

Objective

This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures.

Design

This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups.

Setting

This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers.

Participants

This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures.

Intervention

A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention.

Measurements

Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses.

Results

There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = -1.58 [95% CI = -3.09 to -0.07], intention-to-treat; MD = -1.49 [95% CI = -3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time.

Limitations

Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses.

Conclusions

Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.

SUBMITTER: Gibbs JC

PROVIDER: S-EPMC7439228 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Our goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ?65 years with a vertebral fracture.This pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial.The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups.Five Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services).One hundred sixty women aged ?65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited.The Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ?3 times weekly. Controls will receive equal attention.Primary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05.No assessment of bone mineral density will be conducted. The proposed definitive trial will require a large sample size.The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated, as well as the effects of a home exercise program on important secondary outcomes.

Project description:BackgroundOsteoarthritis (OA) is a common problem in older women that is associated with pain and disabilities. Although yoga is recommended as an exercise intervention to manage arthritis, there is limited evidence documenting its effectiveness, with little known about its long term benefits. This study's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA.MethodsEligible participants (N=36; mean age 72 years) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control. The yoga intervention program was developed by a group of yoga experts (N=5). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score that measures knee OA pain, stiffness, and function at 8 weeks. The secondary outcomes, physical function of the lower extremities, body mass index (BMI), quality of sleep (QOS), and quality of life (QOL), were measured using weight, height, the short physical performance battery (SPPB), the Pittsburgh Sleep Quality Index (PSQI), the Cantril Self-Anchoring Ladder, and the SF12v2 Health Survey. Data were collected at baseline, 4 weeks and 8 weeks, and 20 weeks.ResultsThe recruitment target was met, with study retention at 95%. Based on ANCOVAs, participants in the treatment group exhibited significantly greater improvement in WOMAC pain (adjusted means [SE]) (8.3 [.67], 5.8 [.67]; p=.01), stiffness (4.7 [.28], 3.4 [.28]; p=.002) and SPPB (repeated chair stands) (2.0 [.23], 2.8 [.23]; p=.03) at 8 weeks. Significant treatment and time effects were seen in WOMAC pain (7.0 [.46], 5.4 [.54]; p=.03), function (24.5 [1.8], 19.9 [1.6]; p=.01) and total scores (35.4 [2.3], 28.6 [2.1]; p=.01) from 4 to 20 weeks. Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks. Changes in BMI and QOL were not significant. No yoga related adverse events were observed.ConclusionsA weekly yoga program with home practice is feasible, acceptable, and safe for older women with knee OA, and shows therapeutic benefits.Trial registrationClinicalTrials.gov: NCT01832155.

Project description:Approximately 12% of postmenopausal women have osteoporotic vertebral fractures (VFs); these are associated with excess morbidity and mortality and a high risk of future osteoporotic fractures. Despite this, less than one-third come to clinical attention, partly due to lack of clear clinical triggers for referral for spinal radiographs. The aim of this study was to investigate whether a novel primary care-based screening tool could be used to identify postmenopausal women with osteoporotic VFs and increase appropriate management of osteoporosis. A randomized controlled trial was undertaken in 15 general practices within the Bristol area of the UK. A total of 3200 women aged 65 to 80 years were enrolled, with no exclusion criteria. A simple screening tool was carried out by a nurse in primary care to identify women at high risk of osteoporotic VFs. All identified high-risk women were offered a diagnostic thoracolumbar radiograph. Radiographs were reported using standard National Health Service (NHS) reporting, with results sent back to each participant's general practitioner (GP). Participants in the control arm did not receive the screening tool or radiographs. The main outcome measure was self-reported prescription of medication for osteoporosis at 6 months with a random 5% subsample verified against electronic GP records. Secondary outcome was self-reported incidence of new fractures. Results showed that allocation to screening increased prescription of osteoporosis medications by 124% (odds ratio [OR] for prescription 2.24 at 6 months; 95% confidence interval [CI], 1.16 to 4.33). Allocation to screening also reduced fracture incidence at 12-month follow-up (OR for new fracture 0.60; 95% CI, 0.35-1.03; p = 0.063), although this did not reach statistical significance. This study supports the use of a simple screening tool administered in primary care to increase appropriate prescription of medications for osteoporosis in postmenopausal women in the UK.

Project description:BackgroundEffective and sustainable interventions are needed to counteract the decline in physical function and sarcopenia in the growing aging population. The aim of this study was to determine the 6 and 12 month effectiveness of blended (e-health + coaching) home-based exercise and a dietary protein intervention on physical performance in community-dwelling older adults.MethodsThis cluster randomized controlled trial allocated 45 clusters of older adults already engaged in a weekly community-based exercise programme. The clusters were randomized to three groups with ratio of 16:15:14; (i) no intervention, control (CON); (ii) blended home-based exercise intervention (HBex); and (iii) HBex with dietary protein counselling (HBex-Pro). Both interventions used a tablet PC with app and personalized coaching and were targeting on behaviour change. The study comprised coached 6 month interventions with a 6 month follow-up. The primary outcome physical performance was assessed by modified Physical Performance Test (m-PPT). Secondary outcomes were gait speed, physical activity level (PAL), handgrip muscle strength, protein intake, skeletal muscle mass, health status, and executive functioning. Linear mixed models of repeated measured were used to assess intervention effects at 6 and 12 months.ResultsThe population included 245 older adults (mean age 72 ± 6.5 (SD) years), 71% female, and 54% co-morbidities observed. Dropout of the intervention was 18% at 6 months and 26% at 12 months. Participants were well functioning, based on an m-PPT score of 33.9 (2.8) out of 36. For the primary outcome m-PPT, no significant intervention effects (HBex, +0.03, P = 0.933; HBex-Pro, -0.13, P = 0.730) were found. Gait speed (+0.20 m/s, P = 0.001), PAL (+0.06, P = 0.008), muscle strength (+2.32 kg, P = 0.001), protein intake (+0.32 g/kg/day, P < 0.001), and muscle mass (+0.33 kg, P = 0.017) improved significantly in the HBex-Pro group compared with control group after 6 month intervention. The protein intake, muscle mass, and strength remained significantly improved after 12 months as compared with those of control. Health change and executive functioning improved significantly in both intervention groups after 6 months.ConclusionsThis HBex and dietary protein interventions did not change the physical performance (m-PPT) in community-dwelling older adults. Changes were observed in gait speed, PAL, muscle mass, strength, and dietary protein intake, in response to this combined intervention.

Project description:Vertebral fractures are frequent clinical consequences of osteoporosis. Considering the demographic change in Europe, the number of vertebral fractures will quite likely increase during the next decades. Apart from pharmaceutic agents and physiotherapy, spinal orthoses are established elements of conservative therapy for vertebral (body) fractures. Recent studies on acute vertebral fractures reported positive effects on back pain, kyphosis and functional disabilities, but the efficacy of active strengthening spinal orthoses in vertebral fractures ≥6 months remains to be established. Eighty hyperkyphotic, community-dwelling women ≥65 years with chronic back pain and vertebral fractures occurred ≥3 months ago were randomly allocated to a group which wore the "Spinomed active" orthoses 2 × 2-3 h/d for 16 weeks (SOG: n = 40) or an untreated control group (CG: n = 40). Study outcomes were back pain intensity, kyphosis angle, trunk strength, back pain induced- and general function and disability, functional ability (chair-rise test) and respiratory function. We applied an intention-to-treat analysis; data were consistently adjusted for baseline values applying an ANCOVA. Observing a compliance of 82 ± 14% with the wearing protocol, we determined large and significant favorable effects for back pain (p = .008), back pain-induced physical disability (p < .001) and kyphosis angle (p < .001). We also demonstrated positive effects on trunk strength (p = .049), functional ability (p = .062) and general function and disability (p = .057), although not all of the parameters reach significance. No relevant changes were observed for respiratory function. After a few further individual adjustments of the orthosis (n = 2), no adverse effects were reported. In summary, the present study provided evidence for the efficacy of an active strengthening spinal orthosis ("Spinomed active") in people with vertebral fractures ≥6 months. Based on our results, we recommend expanding the application of the "Spinomed active" orthosis, which was previously validated for acute vertebral fractures, also to older hyperkyphotic women with osteoporotic vertebral fractures ≥3 months.