- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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).
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Arras, Frankrike, 62000
- Rekrytering
- Arras general hospital
-
Kontakt:
- Kathleen Jacquez, MSc
- Telefonnummer: 03.21.21.13.19 / Poste 41319
- E-post: kathleen.jacquez@gh-artoisternois.fr
-
Kontakt:
- Marion FRERE
- E-post: marion.frere@gh-artoisternois.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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)
|
2 times a day, until exit service (excluding weekends), they will climb two floors of stairs (morning and afternoon, supervised by a therapist)
|
|
Inget ingripande: Standard program of rehabilitation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evolution of number of repetitions on chair stand test
Tidsram: at 10 days or at time of study exit if the patient leaves earlier
|
Evolution of number of repetitions in 1 minute on chair stand test between entry and exit of study
|
at 10 days or at time of study exit if the patient leaves earlier
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evolution of dyspnea
Tidsram: at 10 days or at time of study exit if the patient leaves earlier
|
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
|
|
Evolution of distance covered on 6-minute walk test
Tidsram: at 10 days or at time of study exit if the patient leaves earlier
|
Evolution of distance covered on 6-minute walk test between entry and exit of study.
|
at 10 days or at time of study exit if the patient leaves earlier
|
|
Evolution of quality life score
Tidsram: at 10 days or at time of study exit if the patient leaves earlier
|
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.
|
at 10 days or at time of study exit if the patient leaves earlier
|
|
Evolution of muscle mass of lower limb
Tidsram: 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
|
at 10 days or at time of study exit if the patient leaves earlier
|
|
Evolution of heart rate post exercise
Tidsram: at 10 days or at time of study exit if the patient leaves earlier
|
Evolution of heart rate post exercise between entry and exit study
|
at 10 days or at time of study exit if the patient leaves earlier
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Marion FRERE, Arras hospital Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025-01
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