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临床试验/NCT02716493
NCT02716493Unknown不适用

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

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5
试验地点
1
主要终点
Number of adverse events during the 8-week telerehabilitation program

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Number of adverse events during the 8-week telerehabilitation program

时间窗: Along the 8-week program

Adherence of the participants to the 8-week telerehabilitation program.

时间窗: 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

Participants satisfaction with the telerehabilitation platform with the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0)

时间窗: 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).

User satisfaction with health services received with the French version of the Health Care Satisfaction Questionnaire

时间窗: 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.

次要结局

  • 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)
  • Weight(At baseline and following the 8-week program)
  • Height(At baseline and following the 8-week program)
  • Timed up and go test(At baseline and following the 8-week program)
  • Timed stairs test(At baseline and following the 8-week program)
  • Distance achieved during the 6 minutes walking test(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(At baseline and following the 8-week program)
  • Anxiety and depression with the Hospital Anxiety and Depression Scale questionnaire(At baseline and following the 8-week program)
  • Nutritional status with the mini-nutritional assessment(At baseline and following the 8-week program)

研究者

发起方
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
申办方类型
Other
责任方
Principal Investigator
主要研究者

Didier Saey

Dr

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

研究点 (1)

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