Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000970347
Ethics application status
Approved
Date submitted
27/01/2017
Date registered
5/07/2017
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted gluteal exercise program versus sham exercise program for people with hip osteoarthritis (the GHOST trial (Gluteal exercise for Hip OSTeoarthritis): A randomized controlled trial
Scientific title
Targeted gluteal exercise program versus sham exercise program for people with hip osteoarthritis (the GHOST trial (Gluteal exercise for Hip OSTeoarthritis): A randomized controlled trial
Secondary ID [1] 291015 0
Nil
Universal Trial Number (UTN)
U1111-1192-1408
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip osteoarthritis 301791 0
Condition category
Condition code
Musculoskeletal 301483 301483 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of two exercise programs
Participants will be randomly allocated to the GHOst intervention or the sham intervention. Both groups will receive standardised education for hip osteoarthritis, delivered by a physiotherapist and supplemented with handouts. Education will focus on an understanding of the condition and advice on physical activity.

The intervention (Gluteal Hip Osteoarthritis; GHOst) program will consist of once weekly, 30-minute supervised physiotherapy sessions and a self-managed exercise program over 12 weeks. The self-managed home exercise program will consist of the same exercises prescribed during the supervised sessions. The initial physiotherapy session will be a one to one session for one hour, incorporating education and exercises, delivered by the physiotherapist. The additional supervised sessions will be conducted in an individual or group setting (i.e. 1-3 participants per session), based on availability of participants and scheduling of the community physiotherapist. Participants will only attend group sessions with other participants who have been randomised to the same intervention. Whether participants attended group or individual sessions will be documented by the physiotherapist, and accounted for as a covariate in statistical analysis.

The GHOst protocol is composed of three phases; gait retraining, motor control, and pelvic stability with global strengthening. The aim of the gait retraining phase is to normalize, prevent or retard gait related impairments that are commonly associated with hip osteoarthritis. Physiotherapists will instruct participants to normalise stride length and asymmetry. The second phase of the GHOst intervention aims to promote the function of the anterior hip muscles using targeted, functional progressions of a squat and bridge exercise. The third phase of the GHOst protocol aims to improve pelvic stability and overall lower limb and trunk strength and function. These exercises progress from isometric hip hitching exercises, through to high resistance strength training of multiple muscle groups (e.g. double leg squat and dead-lift) with the aid of thera-band and power-bands to achieve the required 'heavy' load dose.

Each phase can begin simultaneously at their first supervised physiotherapy session. Exercises are progressed based on quality (judged by the physiotherapist) and symptoms (pain not exceeding 5/10). All phases will be incorporated into each session, with approximately 5 minutes for gait retraining and the remaining time used for motor control and pelvic stability.

Daily exercise adherence will be monitored with an exercise diary
Intervention code [1] 296986 0
Rehabilitation
Intervention code [2] 297002 0
Lifestyle
Intervention code [3] 297003 0
Treatment: Other
Comparator / control treatment
Sham exercise program
The control group will receive a 12 week sham exercise program not focused on the rehabilitation of gluteal muscles, but still instructed by a physiotherapist. Participants will receive the same number and duration of supervised sessions as the GHOst intervention group. There are four stages of sham gluteal exercises that include gluteal squeezes, seated hip abduction, standing lateral flexion with feet apart and standing lateral trunk flexion with feet together. This will be combined with low resistance quadriceps and calf exercises including seated knee extensions and seated calf raises.

The self-managed home exercise program will consist of the same exercises prescribed during the supervised sessions. Daily exercise adherence will be monitored with an exercise diary. Each phase (e.g. gluteal, quadriceps, calf) can begin simultaneously at their first supervised physiotherapy session. Exercises are progressed based on quality (judged by the physiotherapist) and symptoms (pain not exceeding 5/10). All phases will be incorporated into each session, so that participants complete gluteal, quadriceps and calf exercises in all sessions.
Control group
Placebo

Outcomes
Primary outcome [1] 300877 0
The Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC)- Physical Function item
Timepoint [1] 300877 0
Week 0 (baseline), 7 (mid-intervention), 13 & 27 (post-intervention)
Primary timepoint is 13 weeks
Primary outcome [2] 300889 0
Physical activity by triaxial accelerometry
Timepoint [2] 300889 0
Week 0 (baseline), 13 weeks
Secondary outcome [1] 331090 0
Physical function- 40 m fast-paced walk test
Timepoint [1] 331090 0
Week 0 (baseline), and 13
Secondary outcome [2] 331127 0
Isometric hip strength using handheld dynamometer. Hip abduction, adduction, flexion, extension, internal rotation, external rotation.
Timepoint [2] 331127 0
Weeks 0 (baseline) & 13
Secondary outcome [3] 331128 0
Pain: The average pain over the previous week will be assessed using an 11-point numerical rating scale (NRS), anchored by 0 = “no pain” and 10 = “worst pain possible”.
Timepoint [3] 331128 0
Weeks 0 (baseline), 7, 13 & 27
Secondary outcome [4] 331188 0
Hip dysfunction and Osteoarthritis Outcome Score (HOOS); Oxford Hip Score
Timepoint [4] 331188 0
Weeks 0, 7, 13, 27
Secondary outcome [5] 331189 0
Quality of life as assessed by the Assessment of Quality of Life Questionnaire (AQoL).
Timepoint [5] 331189 0
Weeks 0, 7, 13, 27
Secondary outcome [6] 331190 0
International Physical Activity Screening Questionnaire (Short)
Timepoint [6] 331190 0
Weeks 0, 7, 13, 27
Secondary outcome [7] 335849 0
Pain Catastrophizing Scale
Timepoint [7] 335849 0
Weeks 0 (baseline), 7, 13, 27
Secondary outcome [8] 335872 0
Global Rating of Change: An 11-point scale where participants are asked to rate their overall change in condition.
Timepoint [8] 335872 0
Weeks 7, 13, & 27
Secondary outcome [9] 335875 0
Muscle size. A sub-group of 30 participants only (15 in each group). Muscle size of the lateral hip muscles will be measured using magnetic resonance imaging. One site only
Timepoint [9] 335875 0
Week 0 and 13.
Secondary outcome [10] 335876 0
Gluteus medius and minimus muscle activity - fine-wire electromyography (EMG). Recorded in a sub-group of 30 participants (15 in each group)- one site only
Timepoint [10] 335876 0
Week 0 and 13
Secondary outcome [11] 336403 0
Physical function- Stair climb test
Timepoint [11] 336403 0
0 weeks (baseline) and 13 weeks
Secondary outcome [12] 336404 0
Physical function - Chair stand test
Timepoint [12] 336404 0
0 weeks (baseline) and 13 weeks
Secondary outcome [13] 336405 0
Brief Fear of Movement Scale for Osteoarthritis
Timepoint [13] 336405 0
Weeks 0 (baseline), 7, 13, 27
Secondary outcome [14] 336406 0
Patient Health Questionnaire-9
Timepoint [14] 336406 0
Weeks 0 (baseline), 7, 13, 27
Secondary outcome [15] 336407 0
Muscle adiposity. A sub-group of 30 participants only (15 in each group). Muscle adiposity of the lateral hip muscles will be measured using magnetic resonance imaging. One site only
Timepoint [15] 336407 0
Week 0 and 13.

Eligibility
Key inclusion criteria
(i) aged > 35 years;
(ii) pain in the hip or groin for more than 3 months;
(iii) pain intensity over the past week of 3/10 or more on a numerical rating scale during functional tasks like walking, climbing stairs or climbing in/ out of a car;
(iv) radiographic confirmation of hip osteoarthritis with Kellgren-Lawrence score = 2;
(v) Mild to moderate disability indicated by;
(a) Oxford hip score of 25-45 indicating mild to moderate disability;
(b) Still able to reciprocally ascend and descend 10 stairs unaided;
(c) still able to safely walk one city block;
(d) still able to jog 5 meters
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Volunteers will be ineligible for the following reasons;

(i) Other musculoskeletal lower limb conditions requiring assessment or treatment in the last 6 months;
(ii) Primary complaint of gluteal tendinopathy (clinical diagnosis), low back pain or referred back pain;
(iii) History of hip trauma or surgery on the affected side (leading to secondary hip osteoarthritis);
(iv) Known knee joint pathology or reduced knee range of motion (<90 deg Flexion)
(v) Corticosteroid use (oral or intra-articular) in the past 3 months
(vi) Neurological impairment or condition affecting lower limb function
(vii) Conditions or factors affecting their ability to take part in the exercise intervention, e.g, unavailable for a 12 week intervention period, routine use of gait aids, uncontrolled hypertension, or morbid obesity (BMI>40);
(viii) Systemic inflammatory disease (e.g. rheumatoid arthritis);
(ix) Unable to write, read or comprehend English.

In addition, participants at one site (total of 30 participants) will be asked to complete a magnetic resonance imaging (MRI) scan and undergo fine-wire electromyography (EMG) of gluteus minimus and gluteus medius muscles. These volunteers will be ineligible to participate if they have contraindication to fine-wire EMG (e.g. fear of needles, taking blood thinning medication) or MRI (e.g. pacemaker, claustrophobia).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An investigator (off-site at a central administration site) not involved in participant screening or recruitment will be responsible for generating the allocation sequence (stratified by site). Group allocations will be concealed in serially numbered, opaque, sealed envelopes for each site. These envelopes will be posted to a research assistant at each site who is not involved in participant screening or recruitment. The research assistant will open the envelopes sequentially according to participant number and notify the trial physiotherapist of the participant’s group allocation prior to the participant’s first appointment (after screening for eligibility, enrollment and baseline testing).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a web based randomization program (https://www.randomizer.org/) with a 1:1 allocation ratio stratified by site (4 sites)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimal clinically important difference for the WOMAC is 6 physical function units and the SD of change in WOMAC over 13 weeks is 9.2 units. based on these values, a total sample size of 76 participants (38 per group) is required to detect a clinically important difference between sham and intervention groups, with a power of 80% and an alpha of 0.05. To account for potential drop-outs similar to those reported in previous studies we will recruit 90 participants (45 per group).

Statistical analysis will use intention to treat principles and on a per-protocol basis. Data analysed will focus on detecting the between group treatment and within group treatment effects (with effect sizes and 95% confidence intervals) at each of the follow up time points. A linear mixed model will be used for the primary analysis of the changes in the WOMAC and the accelerometry data due to its advantages in modelling the influence of nonlinear, individual differences over time. Adjustments will be made for the respective baseline outcome measures, as-well as age, sex and BMI. The secondary outcomes will be assessed using t-tests or Mann Whitney U tests, adjusting for baseline differences if required. The global rating of change scale will be dichotomised to define "success" as those with a score of "Moderately Better" to "Very Much Better" (i.e. +3 or more). A generalized mixed model (adjusted for baseline differences and covariates) will be used to assess differences in the proportion of "successes" between groups over each time point.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/07/2017
Actual
10/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 7390 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 15184 0
3550 - Bendigo
Recruitment outside Australia
Country [1] 8608 0
New Zealand
State/province [1] 8608 0
Otago

Funding & Sponsors
Funding source category [1] 295442 0
Charities/Societies/Foundations
Name [1] 295442 0
Arthritis Australia
Country [1] 295442 0
Australia
Funding source category [2] 295443 0
University
Name [2] 295443 0
La Trobe University
Country [2] 295443 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
College of Science, Health & Engineering
PO Box 199
Bendigo
VIC 3552
Country
Australia
Secondary sponsor category [1] 294281 0
None
Name [1] 294281 0
Address [1] 294281 0
Country [1] 294281 0
Other collaborator category [1] 279408 0
University
Name [1] 279408 0
University of Queensland
Address [1] 279408 0
School of Health and Rehabilitation Sciences
St Lucia campus
Brisbane
QLD 4067
Country [1] 279408 0
Australia
Other collaborator category [2] 279409 0
University
Name [2] 279409 0
University of Otago
Address [2] 279409 0
Department of Anatomy
PO Box 913
Dunedin
NZ 9054
Country [2] 279409 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296774 0
Bendigo Health HEC
Ethics committee address [1] 296774 0
Ethics committee country [1] 296774 0
Australia
Date submitted for ethics approval [1] 296774 0
01/02/2017
Approval date [1] 296774 0
05/04/2017
Ethics approval number [1] 296774 0
HREC/17/BHCG/3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72014 0
A/Prof Rod Green
Address 72014 0
College of Science, Health & Engineering
La Trobe University
PO Box 199
Bendigo
VIC 3552
Country 72014 0
Australia
Phone 72014 0
+613 5444 7282
Fax 72014 0
Email 72014 0
[email protected]
Contact person for public queries
Name 72015 0
Rod Green
Address 72015 0
College of Science, Health & Engineering
La Trobe University
PO Box 199
Bendigo
VIC 3552
Country 72015 0
Australia
Phone 72015 0
+613 5444 7282
Fax 72015 0
Email 72015 0
[email protected]
Contact person for scientific queries
Name 72016 0
Rod Green
Address 72016 0
College of Science, Health & Engineering
La Trobe University
PO Box 199
Bendigo
VIC 3552
Country 72016 0
Australia
Phone 72016 0
+613 5444 7282
Fax 72016 0
Email 72016 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTargeted 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.2018https://dx.doi.org/10.1186/s13063-018-2873-3
EmbaseEffects of a targeted resistance intervention compared to a sham intervention on gluteal muscle hypertrophy, fatty infiltration and strength in people with hip osteoarthritis: analysis of secondary outcomes from a randomised clinical trial.2022https://dx.doi.org/10.1186/s12891-022-05907-4
EmbaseComparison between a targeted exercise program and a sham intervention on gluteal muscle activity in people with hip osteoarthritis: Analysis of secondary outcomes from a randomised clinical trial.2023https://dx.doi.org/10.1016/j.gaitpost.2022.11.016
N.B. These documents automatically identified may not have been verified by the study sponsor.