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Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica

2026년 8월 4일 업데이트: Washington University School of Medicine

Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica: a Feasibility Randomized Clinical Trial

Polymyalgia rheumatica (PMR) is a condition that causes joint pain and stiffness, making it hard for people to do everyday tasks. Movement pattern training is a special, personalized rehabilitation program that aims to reduce pain by improving how people move during their daily activities. The investigators plan to test if it's possible to conduct a detailed study to find out how effective Movement pattern training is for people with PMR. The investigators will look at whether it helps them perform activities they want to do, reduce their use of certain medications, and strengthen their muscles. The investigators will also gather feedback from patients about their experience with Movement pattern training. This study will help us understand if carrying out a larger study on Movement pattern training's effectiveness is practical.

연구 개요

상태

아직 모집하지 않음

정황

류마티스성 다발근통(PMR)

개입 / 치료

연구 유형

중재적

등록 (추정된)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Marcie Harris-Hayes, DPT, MSCI
전화번호: 314-286-1435
이메일: harrisma@wustl.edu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

Patient reports a diagnosis or flare of polymyalgia rheumatica (PMR) < 5 months before the screening contact
Diagnosis or flare of PMR according to the European League against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria as follows (must satisfy all criteria)10:
- Age ≥50 years at time of diagnosis
- Presence of bilateral shoulder pain
- Elevated acute phase reactants C-reactive protein (CRP) >10 milligram/Liter and/or Erythrocyte Sedimentation Rate (ESR) >30 millimeters/hour*
- A score ≥4 at the time of diagnosis based on the following (without ultrasound):
  - Duration of morning stiffness >45 minutes: 2 points
  - Hip pain or limited range of motion: 1 point
  - Seronegative for rheumatoid factor and anti-cyclic citrullinated peptide: 2 points
  - Absence of other joint involvement: 1 point
Initiated pharmacological treatment
Able to give informed consent
Physician's clearance to participate in physical activity

Exclusion Criteria:

Diagnosis of fibromyalgia, neuropathic muscular disease, complex regional pain syndrome, or small fiber neuropathy
planned major surgical procedure during the study
Current active uncontrolled infection

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 다른
할당: 무작위
중재 모델: 병렬 할당
마스킹: 더블

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
활성 비교기: Usual Care Patients will be encouraged to complete their treatment as described by their physician.	다른: Usual Care Basic education about polymyalgia rheumatica, benefits of physical activity Patients will be encouraged to participate in physical activity as tolerated Medication as prescribed by their physician
실험적: Movement Pattern Training (MoveTrain) Movement pattern Training (MoveTrain) is progressive activity-specific training to improve altered joint motion during patient-specific tasks. At baseline, each patient identifies specific activities (e.g., getting out of bed), work (e.g., reaching overhead), and physical activities (e.g., cycling) that are difficult due to their pain. A movement examination is performed to identify the altered joint motion on associated with movement-evoked pain and the motion modification that reduces their pain. The treatment provider then instructs the patient in activity-specific training, which includes practicing multiple repetitions of the modified activity as their home exercise program. Patients also are instructed to use the trained modified motion during their daily activities to maximize their use in daily routines. This encourages frequent practice and potentially greater program sustainability.	행동: Movement Pattern Training (MoveTrain) 6 individualized treatment sessions over 10 weeks Motivational interviewing to determine personal goals and strengthen motivation and commitment to change Activity-specific training to practice modified motion during patient-specific tasks, defined as activities reported by each patient as pain-provoking Home exercise program 3 times/week consisting of activities or exercises assigned in the supervised sessions Patient's independence and adherence in performing home exercise program will be documented Patients are encouraged to use modified motion during daily and physical activities Based on patient performance, activity difficulty is progressed by increasing repetitions performed or increasing load or speed

참가자 그룹 / 팔

개입 / 치료

활성 비교기: Usual Care

Patients will be encouraged to complete their treatment as described by their physician.

다른: Usual Care

Basic education about polymyalgia rheumatica, benefits of physical activity
Patients will be encouraged to participate in physical activity as tolerated
Medication as prescribed by their physician

실험적: Movement Pattern Training (MoveTrain)

Movement pattern Training (MoveTrain) is progressive activity-specific training to improve altered joint motion during patient-specific tasks. At baseline, each patient identifies specific activities (e.g., getting out of bed), work (e.g., reaching overhead), and physical activities (e.g., cycling) that are difficult due to their pain. A movement examination is performed to identify the altered joint motion on associated with movement-evoked pain and the motion modification that reduces their pain. The treatment provider then instructs the patient in activity-specific training, which includes practicing multiple repetitions of the modified activity as their home exercise program. Patients also are instructed to use the trained modified motion during their daily activities to maximize their use in daily routines. This encourages frequent practice and potentially greater program sustainability.

행동: Movement Pattern Training (MoveTrain)

6 individualized treatment sessions over 10 weeks

Motivational interviewing to determine personal goals and strengthen motivation and commitment to change
Activity-specific training to practice modified motion during patient-specific tasks, defined as activities reported by each patient as pain-provoking
Home exercise program 3 times/week consisting of activities or exercises assigned in the supervised sessions
Patient's independence and adherence in performing home exercise program will be documented
Patients are encouraged to use modified motion during daily and physical activities
Based on patient performance, activity difficulty is progressed by increasing repetitions performed or increasing load or speed

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Number of potential participants accessed. 기간: 7 months	The total number of people with Polymyalgia rheumatica (PMR) who were recruited each week	7 months
Percent of eligible participants who were willing to be randomized 기간: 7 months	Percent of eligible participants are willing to be randomized during the study	7 months

2차 결과 측정

결과 측정	측정값 설명	기간
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS) 기간: From enrollment to the end of treatment at 10 weeks	The change in polymyalgia rheumatica impact scale (PMR-IS), a self-report questionnaire specific to polymyalgia rheumatica, that represents the patients symptoms and functional ability.	From enrollment to the end of treatment at 10 weeks
Preliminary estimates of change in physical activity 기간: From enrollment to the end of treatment at 10 weeks	The change in physical activity as represented by the Stanford 7-DAy Physical Activity Recall survey	From enrollment to the end of treatment at 10 weeks
Preliminary estimates of change in cumulative glucocorticoid dose 기간: From enrollment to the end of treatment at 10 weeks	Change in cumulative glucocorticoid dose assessed by patient's self-report logs	From enrollment to the end of treatment at 10 weeks
Preliminary estimates of change in muscle strength 기간: From enrollment to the end of treatment at 10 weeks	change in muscle strength of the hips and shoulders, assessed using a hand dynamometer	From enrollment to the end of treatment at 10 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Washington University School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 15일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2026년 7월 24일

QC 기준을 충족하는 최초 제출

2026년 8월 4일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 4일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

202602100

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

This is a feasibility study with only 20 planned participants with limited budget. There is insufficient support for personnel required to prepare the data for sharing purposes.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica