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

5 januari 2017 bijgewerkt door: 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

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

5

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
      • Quebec, Canada
        • CRIUCPQ

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Telerehabilitation group
Patients with unresectable thoracic neoplasia receiving chemotherapy treatment
Gedragsmatig: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of adverse events during the 8-week telerehabilitation program
Tijdsspanne: Along the 8-week program
Along the 8-week program
Adherence of the participants to the 8-week telerehabilitation program.
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cardiopulmonary maximal exercise test (CPET)
Tijdsspanne: 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
Tijdsspanne: At baseline and following the 8-week program
At baseline and following the 8-week program
Isokinetic quadriceps muscle functions
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At baseline and following the 8-week program
Weight (in Kg) of the patient
At baseline and following the 8-week program
Height
Tijdsspanne: 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
Tijdsspanne: At baseline and following the 8-week program
At baseline and following the 8-week program
Timed stairs test
Tijdsspanne: At baseline and following the 8-week program
At baseline and following the 8-week program
Distance achieved during the 6 minutes walking test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At baseline and following the 8-week program
At baseline and following the 8-week program

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2013

Primaire voltooiing (Verwacht)

1 juli 2017

Studie voltooiing (Verwacht)

1 juli 2017

Studieregistratiedata

Eerst ingediend

10 maart 2016

Eerst ingediend dat voldeed aan de QC-criteria

17 maart 2016

Eerst geplaatst (Schatting)

23 maart 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

6 januari 2017

Laatste update ingediend die voldeed aan QC-criteria

5 januari 2017

Laatst geverifieerd

1 januari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20994

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