Dataset Information

Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial - Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial.

ABSTRACT:

Background

Clinical practice guidelines recommend exercise as the first line of management for hip osteoarthritis, yet high-quality evidence from Cochrane reviews suggest only slight benefits for pain and physical function; and no benefit on quality of life (low-quality evidence). However, the scope of physical impairments identified in people with hip osteoarthritis may not have been adequately addressed with targeted rehabilitation options in previous randomised controlled trials (RCTs). Potential targeted options include gait retraining to address spatio-temporal impairments in walking; motor control training to address deep gluteal (gluteus minimus) dysfunction; and progressive, high-intensity resistance exercises to address atrophy of the gluteal muscles. The aim of this study is to investigate the effect of a targeted gluteal rehabilitation programme that incorporates gait retraining, motor control and progressive, high-intensity resistance-strength training, to address physical activity levels and self-reported physical function in people with mild to moderate disability from hip osteoarthritis.

Methods

Ninety people diagnosed with mild to moderately disabling hip osteoarthritis will be recruited and randomised to receive one of two exercise programmes (sham or GHOst programme). Interventions will be 12 weeks in duration, with weekly, supervised physiotherapy sessions, and daily home exercises. Both groups will receive standardised education. Outcomes will be assessed at baseline, 7 weeks, 13 weeks (primary time-point) and 25 weeks. The primary outcome will be self-reported physical function measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include physical activity measured with a tri-axial accelerometer, physical function tests, self-reported physical activity, isometric hip-muscle strength tests, hip-related patient-reported outcome measures, pain thoughts and depressive symptoms, quality of life, global rating of change, gluteal-muscle activity (electromyography (EMG)) and gluteal-muscle size and adiposity (magnetic resonance imaging (MRI)).

Discussion

This will be the first study to compare a targeted gluteal rehabilitation programme to a sham exercise programme. The targeted GHOst programme includes exercises designed to address gait impairments as well as gluteal-muscle atrophy and dysfunction.

Trial registration

Australian New Zealand Clinical Trials Registry, ID: ACTRN12617000970347 . Registered retrospectively on 5 July 2017. Protocol version 3.0.

SUBMITTER: Semciw AI

PROVIDER: S-EPMC6149073 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial - Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial.

Semciw Adam Ivan AI Pizzari Tania T Woodley Stephanie S Zacharias Anita A Kingsley Michael M Green Rod A RA

Trials 20180920 1

<h4>Background</h4>Clinical practice guidelines recommend exercise as the first line of management for hip osteoarthritis, yet high-quality evidence from Cochrane reviews suggest only slight benefits for pain and physical function; and no benefit on quality of life (low-quality evidence). However, the scope of physical impairments identified in people with hip osteoarthritis may not have been adequately addressed with targeted rehabilitation options in previous randomised controlled trials (RCTs ...[more]

PMID: 30236151

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Project description:Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) what is the feasibility of a randomised controlled trial (RCT) investigating a targeted physiotherapy intervention for early-onset hip osteoarthritis (OA) post-hip arthroscopy? and (ii) what are the within-group treatment effects of the physiotherapy intervention and a health-education control group?This study was a pilot single-blind RCT conducted in a private physiotherapy clinic in Hobart, Australia. Patients included 17 volunteers (nine women; age 32 ± 8 years; body mass index = 25.6 ± 5.1 kg/m2) who were recruited 4-14 months post-hip arthroscopy, with chondropathy and/or labral pathology at the time of surgery. Interventions included a physiotherapy treatment program that was semi-standardised and consisted of (i) manual therapy; (ii) hip strengthening and functional retraining; and (iii) health education. Control treatment encompassed individualised health education sessions. The primary outcome measure was feasibility, which was reported as percentage of eligible participants enrolled, adherence with the intervention, and losses to follow-up. The research process was evaluated using interviews, and an estimated sample size for a definitive study is offered. Secondary outcomes included the Hip disability and Osteoarthritis Outcome Score (HOOS) and the International Hip Outcome Tool (IHOT-33) patient-reported outcomes.Seventeen out of 48 eligible patients (35%) were randomised. Adherence to the intervention was 100%, with no losses to follow-up. The estimated sample size for a full-scale RCT was 142 patients. The within-group (95% confidence intervals) change scores for the physiotherapy group were HOOS-Symptoms 6 points (-4 to 16); HOOS-Pain 10 points (-2 to 22); HOOS-Activity of Daily Living 8 points (0 to 16); HOOS-Sport 3 points (-12 to 19); HOOS-Quality of Life 3 points (-7 to 13); and IHOT-33 7 points (-10 to 25). The within-group (95% confidence intervals) change scores for the control group were HOOS-Symptoms -4 points (-17 to 9); HOOS-Pain -2 points (-18 to 13); HOOS-Activity of Daily Living -7 points (-17 to 4); HOOS-Sport 4 points (-16 to 23); HOOS-Quality of Life -5 points (-18 to 9); and IHOT-33 -4 points (-27 to 19). Suggestions to improve study design included greater supervision of exercises and increased access to physiotherapy appointments.Results support the feasibility of a full-scale RCT, and recommendations for an adequately powered and improved study to determine the efficacy of this physiotherapy intervention post-hip arthroscopy to reduce pain and improve function are provided.Australian Clinical Trials Registry, ACTRN12614000426684.

Project description:Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual's functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA.Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based "Musculoskeletal pain in Ullensaker Study" (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives "usual care", whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted.This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA.The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.

Project description:BackgroundOsteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA.Methods/designPatients aged ? 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed.DiscussionThe results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry http://www.trialregister.nl: trial number NTR1462.

Project description:BackgroundProlonged physical impairments in range of movement, postural stability and walking speed are commonly reported following total hip replacement (THR). It is unclear from the current body of evidence what kind of exercises should be performed to maximize patient function and quality of life.Methods/designThis will be a single blind multi centre randomized control trial with two arms. Seventy subjects post primary total hip arthroplasty will be randomized into either an experimental group (n=35), or to a control group (n=35). The experimental group will attend a functional exercise class twice weekly for a six week period from week 12 to week 18 post surgery. The functional exercise group will follow a circuit based functional exercise class supervised by a chartered Physiotherapist. The control group will receive usual care. The principal investigator (BM) will perform blinded outcome assessments on all patients using validated measures for pain, stiffness, and function using the Western Ontario and Mc Master Universities Osteoarthritis index (WOMAC). This is the primary outcome measurement tool. Secondary outcome measurements include Quality of life (SF-36), 6 min walk test, Visual Analogue Scale, and the Berg Balance score. The WOMAC score will be collated on day five post surgery and repeated at week twelve and week eighteen. All other measurements will be taken at week 12 and repeated at week eighteen. In addition a blinded radiologist will measure gluteus medius cross sectional area using real time ultrasound for all subjects at week 12 and at week 18 to determine if the functional exercise programme has any effect on muscle size.DiscussionThis randomised controlled trial will add to the body of evidence on the relationship between muscle size, functional ability, balance, quality of life and time post surgery in patients following total hip arthroplasty. The CONSORT guidelines will be followed to throughout. Ethical approval has been gained from the Ethics committee Health Services Executive Dublin North East.

Project description:OBJECTIVE: To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee. DESIGN: Multicentre, randomised controlled trial. SETTING: 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom. PARTICIPANTS: 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis. INTERVENTIONS: Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119). MAIN OUTCOME MEASURES: The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months. RESULTS: Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval -1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (-0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture. CONCLUSION: The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88597683 [controlled-trials.com] .

Project description:Integrating physical therapy sessions and an online application (e-Exercise) might support people with hip osteoarthritis (OA), knee OA, or both (hip/knee OA) in taking an active role in the management of their chronic condition and may reduce the number of physical therapy sessions.The objective of this study was to investigate the short- and long-term effectiveness of e-Exercise compared to usual physical therapy in people with hip/knee OA.The design was a prospective, single-blind, multicenter, superiority, cluster- randomized controlled trial.The setting included 143 primary care physical therapist practices.The participants were 208 people who had hip/knee OA and were 40 to 80 years of age.e-Exercise is a 3-month intervention in which about 5 face-to-face physical therapy sessions were integrated with an online application consisting of graded activity, exercise, and information modules. Usual physical therapy was conducted according to the Dutch physical therapy guidelines on hip and knee OA.Primary outcomes, measured at baseline after 3 and 12 months, were physical functioning and free-living physical activity. Secondary outcome measures were pain, tiredness, quality of life, self-efficacy, and the number of physical therapy sessions.The e-Exercise group (n = 109) received, on average, 5 face-to-face sessions; the usual physical therapy group (n = 99) received 12. No significant differences in primary outcomes between the e-Exercise group and the usual physical therapy group were found. Within-group analyses for both groups showed a significant improvement in physical functioning. After 3 months, participants in the e-Exercise group reported an increase in physical activity; however, no objectively measured differences in physical activity were found. With respect to secondary outcomes, after 12 months, sedentary behavior significantly increased in the e-Exercise group compared with the usual physical therapy group. In both groups, there were significant improvements for pain, tiredness, quality of life, and self-efficacy.The response rate at 12 months was 65%.The blended intervention, e-Exercise, was not more effective than usual physical therapy in people with hip/knee OA.

Project description:ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.

Dataset Information

Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial - Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial.

Background

Methods

Discussion

Trial registration

Publications

Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial - Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial.

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