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Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)

14 stycznia 2022 zaktualizowane przez: Graziella Brinchault, University of Rennes 2

Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern. It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities). Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects. This alteration is associated with a greater functional limitation and a higher risk of falling. Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life. Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed. The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised. (2) Several clinical factors are associated with these changes.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Oczekiwany)

32

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

COPD patients that realize their medical follow-up at University Hospital of Rennes

Opis

Inclusion Criteria:

  • COPD patients GOLD stage 2 and 3 (A-D)
  • In accordance with Article L1121-8-1 of the Public Health Code, participants must be affiliated to a social security scheme or benefit from such a scheme.

Exclusion Criteria:

  1. the presence of long-term or exercise-based oxygen therapy,
  2. the presence of a medically diagnosed pathology causing manifest disorders of balance,
  3. the inability to walk 150 m without stopping and to climb or descend stairs,
  4. a history of pneumonectomy or lobectomy within the last six months,
  5. the existence of an acute respiratory exacerbation within the last two months,
  6. the presence of obvious cognitive impairment that impairs comprehension of instructions,
  7. body mass index less than 21 or more than 35 kg/m².

  8. Person referred to in articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the public health code:

    • Pregnant woman, woman in labour or nursing mother
    • Person deprived of liberty by judicial or administrative decision
    • Person hospitalised without consent and not subject to a legal protection measure, and person admitted to a health or social establishment for purposes other than research
    • Minor
    • Person subject to a period of exclusion for other research
    • Person of full age subject to a legal protection measure (guardianship, curatorship or safeguard of justice), person of full age unable to express their consent and not subject to a protection measure
  9. Person under psychiatric care

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Zdrowe kontrole
Inny: quantified analysis of postural control during activities of daily living
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
Pacjenci z POChP
Inny: quantified analysis of postural control during activities of daily living
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Margins of stability
Ramy czasowe: Clinical assessment at baseline
Postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Clinical assessment at baseline
Margins of stability variability
Ramy czasowe: Clinical assessment at baseline
Coefficient of variation of a postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Clinical assessment at baseline
Center of Mass velocity
Ramy czasowe: Clinical assessment at baseline
Parameter of participant's Centre of Mass (CoM) during the functional tests
Clinical assessment at baseline
Center of mass displacement
Ramy czasowe: Clinical assessment at baseline
Parameter of participant's Centre of Mass (CoM) during the functional tests
Clinical assessment at baseline

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Evolution of articular angulations
Ramy czasowe: Clinical assessment at baseline
Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests
Clinical assessment at baseline
Centre of pressure (CoP) Area
Ramy czasowe: Clinical assessment at baseline
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Clinical assessment at baseline
Centre of pressure (CoP) velocity
Ramy czasowe: Clinical assessment at baseline
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Clinical assessment at baseline
Centre of pressure (CoP) variability
Ramy czasowe: Clinical assessment at baseline
Coefficient of variation of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Clinical assessment at baseline
Gait Cadence
Ramy czasowe: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Gait velocity
Ramy czasowe: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Gait phases duration
Ramy czasowe: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Step width
Ramy czasowe: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Step length
Ramy czasowe: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Completion time of the Modified Glittre ADL
Ramy czasowe: Clinical assessment at baseline
Time to complete the modified Glittre-ADL test
Clinical assessment at baseline
Completion time of the timed up and go test
Ramy czasowe: Clinical assessment at baseline
Time to complete the timed up and go test test
Clinical assessment at baseline

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Dyspnea assessment scale
Ramy czasowe: Clinical assessment at baseline
assessed by the modified Borg Scale which is a 0 to 10 scale (0 representing no dyspnea, 10 representing the worst imaginable dyspnea). Dyspnea is assessed before, during and after the functional tests
Clinical assessment at baseline
Heart rate
Ramy czasowe: Clinical assessment at baseline
assessed before, during and after functional tests
Clinical assessment at baseline
Leg discomfort scale
Ramy czasowe: Clinical assessment at baseline
assessed on a 0 to 10 scale (0 representing no discomfort, 10 representing the worst imaginable discomfort).Leg discomfort is assessed before, during and after the functional tests
Clinical assessment at baseline
Visual analog scale for pain
Ramy czasowe: Clinical assessment at baseline
Pain is assessed by a visual analog scale which is a 100mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling (Here no pain and the worst imaginable pain)
Clinical assessment at baseline
Pain Drawing scale
Ramy czasowe: Clinical assessment at baseline
participants are invited to identify on a body chart the location of experienced pain.
Clinical assessment at baseline
Multi-dimensional dyspnea profile (MDP)
Ramy czasowe: Clinical assessment at baseline
Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea
Clinical assessment at baseline
London chest activity of daily living questionnaire (LCADL)
Ramy czasowe: Clinical assessment at baseline
Dyspnea assessment tool which investigates the impact of dyspnea on 15 activities of daily living. A score from 0 to 5 is given for each activity, 5 representing an higher impact of dyspnea on the activity.
Clinical assessment at baseline
Modified Medical Research Council Scale (MMRC)
Ramy czasowe: Clinical assessment at baseline
Dyspnea assessment tool which investigates impact of dyspnea in participants life. This is a 0 to 4 scale with descriptors associated to each number. 4 representing the most severe impact of dyspnea.
Clinical assessment at baseline
Charlson Index
Ramy czasowe: Clinical assessment at baseline
Comorbidities assessment tool which list 19 potential comorbidities associated with a weighted score. The points are attributed when the comorbidity is present. A total score is then calculated. An higher score indicates an higher severity.
Clinical assessment at baseline
Body composition
Ramy czasowe: Clinical assessment at baseline
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
Clinical assessment at baseline
Maximal inspiratory pressure
Ramy czasowe: Clinical assessment at baseline
inspiratory muscles strength assessment
Clinical assessment at baseline
Falls Efficacy Scale - International
Ramy czasowe: Clinical assessment at baseline
Fear of falling assessment tool which investigates fear of falling in 16 different activities. Each activity is scored from 0 to 4 (4 representing an higher fear of falling in this activity). The total score range from 16 to 64 (an higher score indicating a most severe fear of falling)
Clinical assessment at baseline
Number of anterior falls
Ramy czasowe: Clinical assessment at baseline
assessment of fall occurence in the last 12 months
Clinical assessment at baseline
General Practioner assessment of Cognition (GP-COG)
Ramy czasowe: Clinical assessment at baseline
assessment of cognitive function. GP-COG gives a score from 0 to 9 (9 indicating a better cognitive function)
Clinical assessment at baseline
International Physical Activity Questionnaire (IPAQ short-form)
Ramy czasowe: Clinical assessment at baseline
assessment of daily physical activity and sedentarity
Clinical assessment at baseline
COPD assessment test (CAT)
Ramy czasowe: Clinical assessment at baseline
quality of life assessment tool
Clinical assessment at baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Rennes 2

Współpracownicy

Rennes University Hospital

Śledczy

  • Główny śledczy: Graziella Brinchault, MD, University Hospital of Rennes

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 lutego 2022

Zakończenie podstawowe (Oczekiwany)

1 września 2022

Ukończenie studiów (Oczekiwany)

1 kwietnia 2023

Daty rejestracji na studia

Pierwszy przesłany

23 listopada 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 stycznia 2022

Pierwszy wysłany (Rzeczywisty)

27 stycznia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 stycznia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 stycznia 2022

Ostatnia weryfikacja

1 stycznia 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • M2S-ATTRACTION

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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