Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Feasibility of a 8-week Telerehabilitation Program for Patients With Thoracic Neoplasia Receiving Chemotherapy (TELErp)

5 stycznia 2017 zaktualizowane przez: Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Feasibility of an Eight-week Telerehabilitation Program for Patients With Unresectable Thoracic Neoplasia Receiving Chemotherapy

Exercise-based rehabilitation improves physical function, fatigue and quality of life in patients with thoracic neoplasia. Consequently, the need for rehabilitation across the continuum of care in oncology is growing rapidly. However, the implementation of this type of intervention is limited because of many barriers such as patients' symptoms and poor accessibility to programs. In this context, healthcare systems should develop and implement new approaches to dispense these services. Consequently, telerehabilitation is a promising strategy to improve access and adherence to rehabilitation.

OBJECTIVES To investigate the feasibility, adherence and satisfaction of a home-based telerehabilitation program (TELERP) with real-time physiological parameters acquisition in patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its effects on patients' functional capacity.

METHODS Five patients receiving chemotherapy followed an 8-week TELERP using real-time monitoring combined with interactive exercises. The TELERP included supervised (15) and unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3 sessions/week. The feasibility of the TELERP, adverse outcomes, technical issues, program adherence and satisfaction were analysed. Prior to and after the program, a six-minute walking test (6MWT), a timed up and go (TUG) and a timed stair test (TST) were done to assess functional capacity

Przegląd badań

Status

Nieznany

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

5

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Kanada
      • Quebec, Kanada
        • CRIUCPQ

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

40 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Patients had to have an ECOG functional status of 0 (Asymptomatic) or 1 (Symptomatic but completely ambulatory);
  • Have a sufficient understanding of verbal and written French instructions
  • Live in a geographic region served by a high speed Internet connection.

Exclusion Criteria:

  • oxygen pulsed saturation (SpO2) <80% during the cardiopulmonary exercise test
  • contraindications to exercise testing according to the American Thoracic Society and American College of Chest Physicians Exercise Testing Guidelines
  • cerebral or bone metastasis
  • a history of significant cardiovascular disease, hypertension, diabetes or musculoskeletal concerns that might limit their ability to perform active exercises
  • severe psychiatric illness compromising adherence to the rehabilitation training routine.

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

  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Telerehabilitation group
Patients with unresectable thoracic neoplasia receiving chemotherapy treatment
Behawioralne: Telerehabilitation program

The intervention was an 8-week home-based telerehabilitation program (three sessions of about 75 minutes per week) using the eChez-Soi telerehabilitation platform.

Through a unique software interface, the eChez-Soi allows for the following three technological aspects: 1- continuous data acquisition and recording from commercial biometric sensors; 2- continuous transmission of the collected data via the Internet to the clinician's computer, allowing the clinician to visualize the biomechanical and physiological parameters in real time; and 3- a challenging gaming environment with interactive exercises performed on musical rhythms.

In total, 15 supervised sessions and 9 unsupervised sessions were planned for a total of 24 exercise sessions

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of adverse events during the 8-week telerehabilitation program
Ramy czasowe: Along the 8-week program
Along the 8-week program
Adherence of the participants to the 8-week telerehabilitation program.
Ramy czasowe: Along the 8-week program
Adherence was defined as the number of sessions done over the prescribed sessions (supervised and unsupervised) and as percentage of time spent within the target heart rate range (intensities) throughout the cardiovascular exercise sessions
Along the 8-week program
Participants satisfaction with the telerehabilitation platform with the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0)
Ramy czasowe: At the end of the 8-week telerehabilitation program
The satisfaction of the patients was evaluated using a questionnaire adapted from the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0) that calculates both satisfaction scores for technological aspects and services. It consists of 12 items rated on a scale from 1 to 5 (1: not satisfied at all to 5: very satisfied).
At the end of the 8-week telerehabilitation program
User satisfaction with health services received with the French version of the Health Care Satisfaction Questionnaire
Ramy czasowe: At the end of the 8-week telerehabilitation program
To assess more specifically the user satisfaction with health services received, we used the French version of the Health Care Satisfaction Questionnaire. This is a 26-item questionnaire answered on a four-point Likert scale, where ''1'' represents ''not at all satisfied'' and ''4'' represents ''highly satisfied". The total score is calculated in percentage and can be computed as the mean overall satisfaction divided in three domains: i) relationship with the professional, ii) delivery of services and iii) organization of services. Higher scores indicate a higher level of satisfaction.
At the end of the 8-week telerehabilitation program

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cardiopulmonary maximal exercise test (CPET)
Ramy czasowe: At baseline and following the 8-week program
At baseline and following the 8-week program
Constant workrate cycle exercise test at 80% of the maximal capacity of the patient
Ramy czasowe: At baseline and following the 8-week program
At baseline and following the 8-week program
Isokinetic quadriceps muscle functions
Ramy czasowe: At baseline and following the 8-week program
Quadriceps muscle function (strength and endurance) was assessed during an isokinetic endurance test performed at a rate of 30 repetitions at 90°/sec of angular velocity (Biodex, system pro 4, Biodex Medical System, 20 Ramsay Road, Shirley, New York )
At baseline and following the 8-week program
Lean body mass
Ramy czasowe: At baseline and following the 8-week program
Lean body mass (in Kg) were measured by bioelectrical impedance analysis (TBF-300WA Tanita, Arlington Heights, IL, USA)
At baseline and following the 8-week program
Fat body mass
Ramy czasowe: At baseline and following the 8-week program
Fat body mass (in Kg) were measured by bioelectrical impedance analysis (TBF-300WA Tanita, Arlington Heights, IL, USA)
At baseline and following the 8-week program
Weight
Ramy czasowe: At baseline and following the 8-week program
Weight (in Kg) of the patient
At baseline and following the 8-week program
Height
Ramy czasowe: At baseline and following the 8-week program
Height (in meters) of the patient
At baseline and following the 8-week program
Timed up and go test
Ramy czasowe: At baseline and following the 8-week program
At baseline and following the 8-week program
Timed stairs test
Ramy czasowe: At baseline and following the 8-week program
At baseline and following the 8-week program
Distance achieved during the 6 minutes walking test
Ramy czasowe: At baseline and following the 8-week program
At baseline and following the 8-week program
Cancer specific quality of life with the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire questionnaire
Ramy czasowe: At baseline and following the 8-week program
The cancer related quality of life was assessed using the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) including the lung cancer specific questionnaire QLQ-LC13
At baseline and following the 8-week program
Anxiety and depression with the Hospital Anxiety and Depression Scale questionnaire
Ramy czasowe: At baseline and following the 8-week program
The French Canadian version of the Hospital Anxiety and Depression Scale (HADS) was used to identify patients suffering of anxiety disorders or depression
At baseline and following the 8-week program
Nutritional status with the mini-nutritional assessment
Ramy czasowe: At baseline and following the 8-week program
At baseline and following the 8-week program

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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

1 listopada 2013

Zakończenie podstawowe (Oczekiwany)

1 lipca 2017

Ukończenie studiów (Oczekiwany)

1 lipca 2017

Daty rejestracji na studia

Pierwszy przesłany

10 marca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 marca 2016

Pierwszy wysłany (Oszacować)

23 marca 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

6 stycznia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 stycznia 2017

Ostatnia weryfikacja

1 stycznia 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20994

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 .

Badania kliniczne na Rak płuc

Badania kliniczne na Telerehabilitation program

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Mongolia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj