Progressive Resistance Training for Adults With External Snapping Hip

Официальное название

Snappy Hip Trial: A Randomized Crossover Trial Comparing the Clinical and Cost-effectiveness of Progressive Resistance Training Compared to Usual Care on Pain for Adults With External Snapping Hip

Обзор

External snapping hip is characterised by an audible and painful snap during hip movement among physical active people around 15-40 years old. Progressive resistance training has been suggested as a new potential treatment path in treating patients with external snapping hip. The investigators conducted a feasibility study and found that patients reported less pain and improved their physical function, quality of life and muscle strength after 12 weeks of progressive resistance training. The overall aim of the project is to compare hip pain in patients with external snapping hip treated with progressive resistance training to a wait-and-see approach, in a randomised controlled trial. This study has the potential to establish a new and specific treatment option for patients with external snapping hip, to be used nationally and internationally.

Подробное описание

This trial is an international multicentre randomised controlled assessor-blinded crossover trial, following the CONSORT guidelines. The intervention is a 12-week progressive resistance training programme, and the trial is designed with three follow-up time points. After the baseline test, the patients will be randomised in a 1:1 ratio to either the intervention or the control group using the Research Electronic Data Capture (REDCap) source hosted at Aarhus University. For both groups, the first test will be the baseline test, conducted before the randomisation. The second test will be conducted 6 weeks after randomisation, the third test will be conducted 12 weeks after randomisation and the fourth and last test will be conducted 24 weeks after randomisation. The primary outcome will be the change from baseline to the third follow-up, and the trial will be powered based on this period. The lasting effect of the intervention will be evaluated from baseline to the fourth follow-up test for the intervention group.

Вмешательства

• Другое Progressive resistance training
  The progressive resistance program consist of a five-minute aerobic warm-up on either an ergometer bike, treadmill or rowing machine followed by six resistance training exercises: landmine twist, walking lunges, leg press, hip abduction, hip adduction and hip flexion. All training sessions (three per week) will be supervised for the first two weeks. After that, there will be one weekly supervised training session and two self-directed sessions. The subjects will be scheduled for 36 training sess
• Поведенческое Waiting time
  12 weeks of waiting time
• Поведенческое Self guided exercise
  12 weeks of self guided exercise

Первичные конечные точки

• HAGOS Pain [Срок оценки: Baseline, week 6, week 12 and week 24]

Вторичные конечные точки (7)

• HAGOS [Срок оценки: Baseline, week 6, week 12 and week 24]
• UCLA-AS [Срок оценки: Baseline, week 12 and week 24]
• GPE [Срок оценки: Baseline, week 12 and week 24]
• Single leg hop test [Срок оценки: Baseline, week 12 and week 24]
• 30 second unilateral sit-to-stand test [Срок оценки: Baseline, week 12 and week 24]
• Number of training sessions the participant participated in [Срок оценки: Throughout the study, summed in week 24]
• Adverse events [Срок оценки: Throughout the study, summed in week 24]

Критерии участия

Критерии включения

• Age 18-40 years (10)
• Experienced lateral hip joint "snapping" with pain discomfort within the last 14 days
• Able to demonstrate the audible and/or visible lateral "snapping" during lateral hip joint movementor popping sound when the hip joint moves
• Capable of commuting to the training facility
• Proficient in reading and understanding Danish or English

Критерии исключения

• Previous surgery on the affected hip
• Planned surgery on lower extremities within the trial period
• Anterior or medial hip discomfort that substantially exceeds the lateral hip discomfort
• Any contraindication to exercise
• Neurological, rheumatoid, or mental conditions affecting the hip function
• Ongoing active cancer treatment
• Planned vacation for more than 14 days within the intervention period
• Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 13 центров

• Aalborg Universitetshospital — Aalborg
• Aarhus University Hospital — Aarhus N
• Rigshospitalet — Copenhagen
• Bispebjerg og Frederiksberg Hospital — Copenhagen
• Regionshospitalet Gødstrup — Herning
• Nordsjællands Hospital - Hillerød — Hillerød
• Regionshospitalet Horsens — Horsens
• Hvidovre Hospital — Hvidovre
• … и ещё 5 центров

Идентификаторы

NCT: NCT06924164 · Snappy Hip Tirial · 4308-00012B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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