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| ID | Type | Description | Link |
|---|---|---|---|
| 336293 | Other Identifier | Integrated Research Application System (IRAS) | |
| 25/PR/0403 | Other Identifier | Health Research Authority (HRA) approval |
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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
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Greater Trochanteric Pain Syndrome (GTPS) is a condition that causes pain on the outer side of the hip. This clinical trial tests a simple exercise timing approach for adults with GTPS.
The main questions it aims to answer are:
Researchers will compare three groups. Each group receives different guidance on when to do their exercises. This will show whether timing guidance (with or without reminders) works better than usual care.
Participants will:
Adults aged 18 and over may take part if they:
Taking part may help participants keep up with their prescribed exercises, which may in turn reduce hip pain and improve daily activities. It could also help researchers find better ways to support people with GTPS in the future.
Background and Rationale: Greater Trochanteric Pain Syndrome (GTPS) is a common musculoskeletal condition affecting the lateral hip, with an estimated prevalence of 10-25% in the general population and a disproportionately higher incidence among middle-aged women. The condition is characterised by pain and tenderness localised to the greater trochanter, most commonly attributed to gluteal tendinopathy (particularly of the gluteus medius and minimus tendons) and trochanteric bursitis. GTPS can significantly impair functional capacity, quality of life, and participation in daily activities.
Current evidence supports therapeutic exercise, including progressive hip-strengthening programmes, as a first-line treatment for GTPS. Despite this, the clinical effectiveness of exercise-based rehabilitation is substantially undermined by poor patient adherence to prescribed programmes. Non-adherence is a persistent and well-documented challenge across musculoskeletal rehabilitation settings, contributing to suboptimal outcomes, prolonged symptom duration, and increased healthcare utilisation. Scalable, low-resource strategies to support adherence in this population are lacking.
Theoretical Framework: The ASAP (As Soon As Possible) intervention is grounded in established behavioural science theory on motivational resource depletion and self-regulatory capacity throughout the day. Research in ego depletion and time-of-day effects on self-control suggests that motivational resources and executive function are relatively stronger in the early waking hours and decline progressively as cognitive and decisional demands accumulate throughout the day. Consequently, health-related behaviours that require deliberate effort or involve discomfort, such as adherence to a therapeutic exercise programme, are more vulnerable to avoidance or abandonment when deferred to later in the day.
The ASAP intervention operationalises this framework by encouraging participants to complete their prescribed exercises as early as possible each day, ideally immediately or shortly after waking. The rationale is that performing exercises during a window of higher motivational resources reduces the likelihood that competing demands will displace the exercise behaviour. This approach is designed to be pragmatic, requiring no specialised equipment, additional clinical contact, or complex behaviour change techniques beyond the provision of psychoeducational information and, in one arm, periodic digital reinforcement.
Study Design: This is a three-arm, parallel-group feasibility randomised controlled trial (RCT) with an embedded qualitative component. Participants are allocated in a 1:1:1 ratio to one of three groups using computer-generated block randomisation (block size of six) administered via Sealed Envelope, an established online randomisation platform. The three-arm structure enables simultaneous evaluation of (1) the ASAP timing concept relative to usual care, and (2) the incremental value of digital reminders as an adherence-support adjunct.
All participants are recruited through the Sport and Exercise Medicine clinic at University Hospitals of Leicester NHS Trust and receive the same hip-strengthening exercise programme prescribed by their NHS healthcare provider as part of standard clinical care. The exercise programme itself is not an experimental variable; the intervention under investigation concerns exclusively the timing guidance and reminder components layered onto standard care.
Intervention Arms:
Group A - ASAP with Reminders: Participants receive a written information leaflet explaining the theoretical basis for early-morning exercise completion and its anticipated benefit for adherence. In addition, participants receive weekly digital reminders (delivered via a messaging platform) throughout the 28-day primary intervention period. These reminders reinforce the ASAP timing message and prompt participants to prioritise morning exercise completion.
Group B - ASAP without Reminders: Participants receive the same information leaflet as Group A but do not receive any digital reminders. This arm isolates the effect of the written psychoeducational component from the reminder-augmented condition.
Group C - Usual Care Control: Participants proceed with their prescribed hip exercise programme without receiving any additional timing guidance, written information relating to exercise timing, or digital reminders. This arm reflects current standard practice and serves as the comparator condition.
Feasibility Objectives: As a feasibility trial, the primary aim is to evaluate the practicability and preparatory requirements for a future definitive full-scale RCT. Specific feasibility criteria include:
Recruitment rate: The rate at which eligible participants are identified, approached, and successfully enrolled over the recruitment period.
Retention rate: The proportion of enrolled participants who complete follow-up assessments at each pre-specified time point, including the primary endpoint at Day 28.
Questionnaire completion rate: The proportion of completed data fields across all outcome measure timepoints, including the daily adherence survey.
Participant acceptability: Qualitative and quantitative assessment of participants' experiences of the intervention, study procedures, and perceived burden.
These parameters will inform sample size calculations, outcome selection, and procedural refinements for the design of a future definitive trial.
Data Collection and Assessment Schedule: All data collection is conducted online via a secure digital platform. Participants complete a standardised battery of validated outcome measures at five timepoints: baseline (Day 1), Day 14, Day 28, Day 42, and Day 84. This schedule is designed to capture short-term adherence behaviour and early symptomatic response (Day 14 and Day 28), medium-term outcomes following the active intervention period (Day 42), and longer-term maintenance of effect (Day 84).
In addition, participants complete a brief daily adherence survey for the first 28 days of the intervention period. This survey is estimated to take 1-2 minutes per day and captures self-reported exercise timing and completion, as well as any relevant contextual factors affecting adherence on that day.
Qualitative Component: Following completion of the quantitative phase, a purposively sampled subset of participants across all three arms will be invited to participate in online focus group discussions. These discussions will be conducted using a semi-structured topic guide and will explore participants' subjective experiences of the intervention, perceived barriers and facilitators to morning exercise timing, the acceptability of the study procedures and digital components, and suggestions for intervention refinement. Focus groups will be audio-recorded, transcribed verbatim, and analysed using an appropriate qualitative framework methodology. Qualitative findings will be integrated with quantitative feasibility data to provide a comprehensive basis for informing a future definitive trial.
Clinical Setting: Initial participant identification and recruitment takes place at the Sport and Exercise Medicine clinic at University Hospitals of Leicester NHS Trust. Following enrolment, the study is conducted entirely online, enabling participation from any location with internet access and supporting engagement from participants who may have mobility limitations or scheduling constraints associated with their GTPS diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (ASAP with reminders) | Experimental | Participants receive an information leaflet explaining the rationale for early-morning exercise and a weekly digital reminder reinforcing adherence to the ASAP schedule |
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| Group B (ASAP without reminders) | Experimental | Participants receive the same information leaflet but no reminders |
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| Group C (Usual care control) | No Intervention | Participants continue their prescribed exercises without any additional timing guidance or reminders |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhancing exercise adherence among patients with lateral hip pain | Behavioral | Time-based motivational intervention to improve exercise adherence |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | The number of patients invited to participate and the number who provide informed consent at end of recruitment period. | through study completion, an average of 1 year |
| Retention Rate | The number of participants who withdraw from the study and those who do not complete their scheduled online follow-up questionnaires. | through study completion, an average of 1 year |
| Completion Rate | The proportion of participants who fully complete all outcome measurement scales at each scheduled assessment point. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The Exercise Adherence Scale (EXAS) | A five-item daily self-report survey completed online for 28 consecutive days. The survey takes approximately 1-2 minutes to complete. It captures both exercise adherence (whether exercises were done) and exercise timing (when they were done), which is the primary focus of the ASAP intervention. | Daily from Baseline (Day 1) up to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wafa R Alrubaia, MSc | Contact | +447472358659 | W.R.S.Alrubaia@lboro.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ian Taylor, PhD | School of Sport, Exercise and Health Sciences, Loughborough University | Principal Investigator |
| Florence Kinnafick, PhD | School of Sport, Exercise and Health Sciences, Loughborough University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHT Trust, Department of Musculoskeletal, Sport & Exercise Medicine | Recruiting | Leicester | Leictershaire | LE5 4PW | United Kingdom |
IPD will not be shared as this is a feasibility trial with a small sample size and preliminary exploratory data.
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Participants are informed that the study investigates strategies to support adherence to prescribed hip-strengthening exercises and that they will be placed into one of three groups, each receiving different guidance on exercise timing. However, participants are not informed of the specific study hypothesis, or the details of between-group comparisons. This partial masking is intended to minimise expectancy effects and reduce performance bias. Full debriefing will be provided to all participants upon completion of the study.
| The Exercise Adherence Rating Scale (EARS)- Section B | A validated patient-reported outcome measure developed to assess adherence to home exercise programmes in people with musculoskeletal conditions. Section B specifically captures participants' reasons for not fully adhering to their prescribed exercise programme, including barriers such as pain, time constraints, and forgetting. | Day 7, Day 28, Day 42, and Day 84 (up to 12 weeks) |
| Morningness-Eveningness Questionnaire (MEQ) | A validated 19-item self-report measure developed by Horne and Östberg (1976) to assess chronotype - an individual's natural preference for morning or evening activity. Participants select their preferred times for sleeping, waking, and performing tasks across a range of scenarios. Total scores range from 16 to 86, with higher scores indicating a stronger morning preference. Scores are classified into five chronotype categories: definitely morning type (70-86), moderately morning type (59-69), intermediate type (42-58), moderately evening type (31-41), and definitely evening type (16-30). | Day 1 (Baseline) |
| Victorian Institute of Sport Assessment - Gluteal Tendinopathy (VISA-G) | A validated 8-item patient-reported outcome measure developed by Fearon et al. (2015) specifically to assess pain and function in individuals with gluteal tendinopathy. Items cover pain during daily activities, functional ability, and capacity to participate in sport or work. Total scores range from 0 to 100, with higher scores indicating less pain and better function. A score of 100 represents full asymptomatic participation in all activities. | Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks) |
| Non-Arthritic Hip Score (NAHS) | A validated 20-item patient-reported outcome measure developed by Christensen et al. (2003) to assess hip pain and function in individuals with non-arthritic hip conditions, including Greater Trochanteric Pain Syndrome (GTPS). It covers four domains: pain, mechanical symptoms, physical function, and sports or recreational activities. Each item is scored on a five-point scale (0-4) and total scores are converted to a 0-100 scale, with higher scores indicating better hip function and less pain. A score of 100 represents no pain or functional limitation. | Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks) |
| Musculoskeletal Health Questionnaire (MSK-HQ) | A validated 14-item patient-reported outcome measure developed by Hill et al. (2016) at Keele University to assess musculoskeletal health across a range of conditions. It covers pain severity, physical function, sleep, fatigue, emotional wellbeing, and ability to carry out daily activities. Each item is scored on a five-point scale (0-4), giving a total score range of 0 to 56, with higher scores indicating better musculoskeletal health. | Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks) |
| Pain Numerical Rating Scale (NRS) | A widely used, validated single-item measure of pain intensity. Participants rate their current pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. It is quick to administer, taking less than one minute to complete, and has been validated across a range of musculoskeletal conditions. | Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks) |
| The Tampa Scale for Kinesiophobia (TSK) | A validated self-report measure of fear of movement and re-injury, originally developed by Miller et al. (1991). Participants rate their level of agreement with statements about pain, movement, and physical activity on a four-point Likert scale (1 = strongly disagree to 4 = strongly agree). Higher scores indicate greater fear of movement. It is completed online at baseline and at each follow-up assessment. | Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks) |
| Theoretical Framework of Acceptability Questionnaire (TFA-Q) | A validated measure developed by Sekhon et al. (2017) to assess the acceptability of healthcare interventions from the participant's perspective. It evaluates seven constructs: affective attitude (how the participant feels about the intervention), burden (perceived effort required), ethicality (fit with personal values), intervention coherence (understanding of the intervention), opportunity costs (what is given up to participate), perceived effectiveness (belief that the intervention will work), and self-efficacy (confidence in completing the intervention behaviours). Each item is rated on a five-point Likert scale, with higher scores indicating greater acceptability. | Day 84 (up to 12 weeks) |