Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716493
Recruitment Status : Unknown
Verified January 2017 by Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec.
Recruitment status was:  Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Telerehabilitation program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Feasibility of an Eight-week Telerehabilitation Program for Patients With Unresectable Thoracic Neoplasia Receiving Chemotherapy
Study Start Date : November 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telerehabilitation group
Patients with unresectable thoracic neoplasia receiving chemotherapy treatment
Behavioral: 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





Primary Outcome Measures :
  1. Number of adverse events during the 8-week telerehabilitation program [ Time Frame: Along the 8-week program ]
  2. Adherence of the participants to the 8-week telerehabilitation program. [ Time Frame: 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

  3. Participants satisfaction with the telerehabilitation platform with the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0) [ Time Frame: 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).

  4. User satisfaction with health services received with the French version of the Health Care Satisfaction Questionnaire [ Time Frame: 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.


Secondary Outcome Measures :
  1. Cardiopulmonary maximal exercise test (CPET) [ Time Frame: At baseline and following the 8-week program ]
  2. Constant workrate cycle exercise test at 80% of the maximal capacity of the patient [ Time Frame: At baseline and following the 8-week program ]
  3. Isokinetic quadriceps muscle functions [ Time Frame: 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 )

  4. Lean body mass [ Time Frame: 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)

  5. Fat body mass [ Time Frame: 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)

  6. Weight [ Time Frame: At baseline and following the 8-week program ]
    Weight (in Kg) of the patient

  7. Height [ Time Frame: At baseline and following the 8-week program ]
    Height (in meters) of the patient

  8. Timed up and go test [ Time Frame: At baseline and following the 8-week program ]
  9. Timed stairs test [ Time Frame: At baseline and following the 8-week program ]
  10. Distance achieved during the 6 minutes walking test [ Time Frame: At baseline and following the 8-week program ]
  11. Cancer specific quality of life with the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire questionnaire [ Time Frame: 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

  12. Anxiety and depression with the Hospital Anxiety and Depression Scale questionnaire [ Time Frame: 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

  13. Nutritional status with the mini-nutritional assessment [ Time Frame: At baseline and following the 8-week program ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716493


Locations
Layout table for location information
Canada
CRIUCPQ
Quebec, Canada
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Layout table for additonal information
Responsible Party: Didier Saey, Dr, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT02716493    
Other Study ID Numbers: 20994
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Keywords provided by Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Telerehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms