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

NCT02716493 | Unknown

• 1 other identifier: 20994
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

Telerehabilitation

Outcome Measures

Primary Outcomes (4)

• Number of adverse events during the 8-week telerehabilitation program

  Along the 8-week program

• Adherence of the participants to the 8-week telerehabilitation 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)

  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

  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

Secondary Outcomes (13)

• Cardiopulmonary maximal exercise test (CPET)

  At baseline and following the 8-week program

• Constant workrate cycle exercise test at 80% of the maximal capacity of the patient

  At baseline and following the 8-week program

• Isokinetic quadriceps muscle functions

  At baseline and following the 8-week program

• Lean body mass

  At baseline and following the 8-week program

• Fat body mass

  At baseline and following the 8-week program

Study Arms (1)

Telerehabilitation group

EXPERIMENTAL

Patients with unresectable thoracic neoplasia receiving chemotherapy treatment

Behavioral: Telerehabilitation program

Interventions

Telerehabilitation program BEHAVIORAL

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

Telerehabilitation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

CRIUCPQ

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 23, 2016
• Study Start: November 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

CA (1)