このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

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

調査の概要

状態

わからない

条件

研究の種類

介入

入学 (実際)

5

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Telerehabilitation group
Patients with unresectable thoracic neoplasia receiving chemotherapy treatment

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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of adverse events during the 8-week telerehabilitation program
時間枠:Along the 8-week program
Along the 8-week program
Adherence of the participants to the 8-week telerehabilitation program.
時間枠: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)
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Cardiopulmonary maximal exercise test (CPET)
時間枠: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
時間枠:At baseline and following the 8-week program
At baseline and following the 8-week program
Isokinetic quadriceps muscle functions
時間枠: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
時間枠: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
時間枠: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
時間枠:At baseline and following the 8-week program
Weight (in Kg) of the patient
At baseline and following the 8-week program
Height
時間枠: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
時間枠:At baseline and following the 8-week program
At baseline and following the 8-week program
Timed stairs test
時間枠:At baseline and following the 8-week program
At baseline and following the 8-week program
Distance achieved during the 6 minutes walking test
時間枠: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
時間枠: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
時間枠: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
時間枠:At baseline and following the 8-week program
At baseline and following the 8-week program

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年11月1日

一次修了 (予想される)

2017年7月1日

研究の完了 (予想される)

2017年7月1日

試験登録日

最初に提出

2016年3月10日

QC基準を満たした最初の提出物

2016年3月17日

最初の投稿 (見積もり)

2016年3月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2017年1月6日

QC基準を満たした最後の更新が送信されました

2017年1月5日

最終確認日

2017年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 20994

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する