The 'As Soon As Possible (ASAP)' Intervention for Enhancing Therapeutic Exercise Adherence Among Patients With Greater Trochanteric Pain Syndrome (GTPS): A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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:
- Can enough people with GTPS be recruited and complete this study?
- How many participants fill in their questionnaires at all five check-ins?
- Do participants find the exercise timing approach easy and acceptable?
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:
- Follow a prescribed hip exercise programme set by their healthcare provider
- Fill in a short daily survey (1-2 minutes) for 28 days
- Complete online questionnaires about hip pain, movement, and exercise at five - points over about three months
- Join an online group discussion at the end of the study
Adults aged 18 and over may take part if they:
- Have been diagnosed with GTPS by a healthcare provider
- Are able to exercise safely
- Own a mobile phone
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Greater Trochanteric Pain Syndrome (GTPS): Participants must have been diagnosed with GTPS by a qualified healthcare provider
- •Age: Participants aged 18 years or above
- •Willingness to Participate: Participants must express a willingness to participate in the study
- •Ability to Understand and Provide Informed Consent: Participants must be able to comprehend the study details, provide informed consent, and actively engage in the intervention and assessment processes
- •Ability to Perform Prescribed Exercises: Participants should be physically able to perform the prescribed exercises safely to actively engage in the intervention as assessed by their NHS treating healthcare practitioner
- •Having a mobile phone
排除标准
- •Age: Participants aged under 18 years.
- •Severe Medical or Psychiatric Conditions: Participants who suffer from severe medical or psychiatric disorders that could significantly impact their ability to engage in the intervention or comply with the exercise program will not be included.
研究组 & 干预措施
Group A (ASAP with reminders)
Participants receive an information leaflet explaining the rationale for early-morning exercise and a weekly digital reminder reinforcing adherence to the ASAP schedule
干预措施: Enhancing exercise adherence among patients with lateral hip pain (Behavioral)
Group B (ASAP without reminders)
Participants receive the same information leaflet but no reminders
干预措施: Enhancing exercise adherence among patients with lateral hip pain (Behavioral)
Group C (Usual care control)
Participants continue their prescribed exercises without any additional timing guidance or reminders
研究者
Wafa Alrubaia
Principal Investigator
Loughborough University
