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Идёт набор NCT07597343

Enhancing Exercise Adherence Among Patients With Lateral Hip Pain

Без фазы С лечением Greater Trochanter Pain Syndrome Hip Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Enhancing exercise adherence among patients with lateral hip pain.
Кому может быть актуально
Состояния в реестре: Greater Trochanter Pain Syndrome, Hip Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The 'As Soon As Possible (ASAP)' Intervention for Enhancing Therapeutic Exercise Adherence Among Patients With Greater Trochanteric Pain Syndrome (GTPS): A Feasibility Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Enhancing exercise adherence among patients with lateral hip pain
    Time-based motivational intervention to improve exercise adherence

Первичные конечные точки

  • Recruitment Rate [Срок оценки: through study completion, an average of 1 year]
  • Retention Rate [Срок оценки: through study completion, an average of 1 year]
  • Completion Rate [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (9)
  • The Exercise Adherence Scale (EXAS) [Срок оценки: Daily from Baseline (Day 1) up to Day 28]
  • The Exercise Adherence Rating Scale (EARS)- Section B [Срок оценки: Day 7, Day 28, Day 42, and Day 84 (up to 12 weeks)]
  • Morningness-Eveningness Questionnaire (MEQ) [Срок оценки: Day 1 (Baseline)]
  • Victorian Institute of Sport Assessment - Gluteal Tendinopathy (VISA-G) [Срок оценки: Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks)]
  • Non-Arthritic Hip Score (NAHS) [Срок оценки: Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks)]
  • Musculoskeletal Health Questionnaire (MSK-HQ) [Срок оценки: Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks)]
  • Pain Numerical Rating Scale (NRS) [Срок оценки: Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks)]
  • The Tampa Scale for Kinesiophobia (TSK) [Срок оценки: Baseline (Day 1), Day 28, Day 42, and Day 84 (up to 12 weeks)]
  • Theoretical Framework of Acceptability Questionnaire (TFA-Q) [Срок оценки: Day 84 (up to 12 weeks)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • University Hospitals of Leicester NHT Trust, Department of Musculoskeletal, Sport & Exerci — Leicester

Идентификаторы

NCT: NCT07597343 · 25/PR/0403 · 336293 · 25/PR/0403

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗