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

5. ledna 2017 aktualizováno: 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

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

5

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
      • Quebec, Kanada
        • CRIUCPQ

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Telerehabilitation group
Patients with unresectable thoracic neoplasia receiving chemotherapy treatment
Behaviorální: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of adverse events during the 8-week telerehabilitation program
Časové okno: Along the 8-week program
Along the 8-week program
Adherence of the participants to the 8-week telerehabilitation program.
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cardiopulmonary maximal exercise test (CPET)
Časové okno: 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
Časové okno: At baseline and following the 8-week program
At baseline and following the 8-week program
Isokinetic quadriceps muscle functions
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At baseline and following the 8-week program
Weight (in Kg) of the patient
At baseline and following the 8-week program
Height
Časové okno: 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
Časové okno: At baseline and following the 8-week program
At baseline and following the 8-week program
Timed stairs test
Časové okno: At baseline and following the 8-week program
At baseline and following the 8-week program
Distance achieved during the 6 minutes walking test
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At baseline and following the 8-week program
At baseline and following the 8-week program

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2013

Primární dokončení (Očekávaný)

1. července 2017

Dokončení studie (Očekávaný)

1. července 2017

Termíny zápisu do studia

První předloženo

10. března 2016

První předloženo, které splnilo kritéria kontroly kvality

17. března 2016

První zveřejněno (Odhad)

23. března 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

6. ledna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. ledna 2017

Naposledy ověřeno

1. ledna 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 20994

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