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

4. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Marcie Harris-Hayes, DPT, MSCI
  • Telefonnummer: 314-286-1435
  • E-post: harrisma@wustl.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Usual Care
Patients will be encouraged to complete their treatment as described by their physician.
Annen: 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
Eksperimentell: 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.
Atferdsmessig: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of potential participants accessed.
Tidsramme: 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
Tidsramme: 7 months
Percent of eligible participants are willing to be randomized during the study
7 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Washington University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. august 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

24. juli 2026

Først innsendt som oppfylte QC-kriteriene

4. august 2026

Først lagt ut (Faktiske)

6. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202602100

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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