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

4. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Polymyalgia rheumatica (PMR)

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Marcie Harris-Hayes, DPT, MSCI
Telefonnummer: 314-286-1435
E-Mail: harrisma@wustl.edu

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Sonstiges
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Doppelt

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Aktiver Komparator: Usual Care Patients will be encouraged to complete their treatment as described by their physician.	Sonstiges: 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
Experimental: 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.	Verhalten: 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

Teilnehmergruppe / Arm

Intervention / Behandlung

Aktiver Komparator: Usual Care

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

Sonstiges: 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

Experimental: 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.

Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Number of potential participants accessed. Zeitfenster: 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 Zeitfenster: 7 months	Percent of eligible participants are willing to be randomized during the study	7 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS) Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Washington University School of Medicine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. August 2026

Primärer Abschluss (Geschätzt)

31. März 2027

Studienabschluss (Geschätzt)

31. März 2027

Studienanmeldedaten

Zuerst eingereicht

24. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. August 2026

Zuerst gepostet (Tatsächlich)

6. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

202602100

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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