- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07693348
Impact of Daily Stair Climbing on Cardiopulmonary Rehabilitation in Heart Patients (RIME)
Impact of Daily Stair Climbing on Cardiopulmonary Rehabilitation in Heart Patients : Single-center Comparative Study in Eole Unit of Arras Hospital Center
The goal of this interventional study is to improve exercise capacity of patients following a standard rehabilitation program in Arras Hospital with stair climbing .
Patients will be randomized in to 2 groups : intervention or control.
- Control group will follow standard program.
- Intervention group will follow standard program and stair climbing (2 floors, twice a day until the exit).
Patients will complete questionnaires and tests before starting study and again at the end (approximately 10 days).
Studieoversigt
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Arras, Frankrig, 62000
- Rekruttering
- Arras general hospital
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Kontakt:
- Kathleen Jacquez, MSc
- Telefonnummer: 03.21.21.13.19 / Poste 41319
- E-mail: kathleen.jacquez@gh-artoisternois.fr
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Kontakt:
- Marion FRERE
- E-mail: marion.frere@gh-artoisternois.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age ≥18 years
- Patients requiring cardiac rehabilitation admitted to the Eole unit
- Patients ability to walk at least 200 meters without technical assistance
Exclusion Criteria:
- Patient walking with an assistive device
- Patient with a contraindication to climbing stairs
- Pre-operative patient
- Patient with a pacemaker
- Patient with an implanted defibrillator
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Standard program of rehabilitation
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Eksperimentel: standard program of rehabilitation + stair climb
Patients will follow standard program + 2 times a day, until exit service (excluding weekends), they will climb two floors of stairs (morning and afternoon, supervised by a therapist)
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2 times a day, until exit service (excluding weekends), they will climb two floors of stairs (morning and afternoon, supervised by a therapist)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Evolution of number of repetitions on chair stand test
Tidsramme: at 10 days or at time of study exit if the patient leaves earlier
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Evolution of number of repetitions in 1 minute on chair stand test between entry and exit of study
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at 10 days or at time of study exit if the patient leaves earlier
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evolution of dyspnea
Tidsramme: at 10 days or at time of study exit if the patient leaves earlier
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Evolution of dyspnea (with Modified Medical Research Council (mMRC) scale) between entry and exit of study. The scale is from 0 to 4. The higher the stage, the more severe the dyspnea. |
at 10 days or at time of study exit if the patient leaves earlier
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Evolution of distance covered on 6-minute walk test
Tidsramme: at 10 days or at time of study exit if the patient leaves earlier
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Evolution of distance covered on 6-minute walk test between entry and exit of study.
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at 10 days or at time of study exit if the patient leaves earlier
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Evolution of quality life score
Tidsramme: at 10 days or at time of study exit if the patient leaves earlier
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Evolution of quality life score with the World Health Organization Quality of Life Bref (WHOQOL Bref) questionnaire between entry and exit study.
Measures overall quality of life in four domains: physical, psychological, social relationships, and environment.
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at 10 days or at time of study exit if the patient leaves earlier
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Evolution of muscle mass of lower limb
Tidsramme: at 10 days or at time of study exit if the patient leaves earlier
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Evolution of muscle mass in lower limb muscle mass measured by bioelectrical impedance between entry and exit of study
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at 10 days or at time of study exit if the patient leaves earlier
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Evolution of heart rate post exercise
Tidsramme: at 10 days or at time of study exit if the patient leaves earlier
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Evolution of heart rate post exercise between entry and exit study
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at 10 days or at time of study exit if the patient leaves earlier
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Marion FRERE, Arras hospital Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2025-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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