Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients
Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.
Design: this pilot-study uses a two-group random assignment pretest-posttest design. Once the groups are being selected an envelope will be mailed to the participant with the printed version of the exercise program and surveys, a portable SpiroBank Smart FN multi parameter spirometer (MIR), a finger pulse oximeter (LOOKEE), a diary, and a prepaid envelop for a subsequent post-intervention return of the equipment and surveys and the diary.
Intervention: A) Exercise program: evidence-based and user friendly educational materials with recommendations on breathing and physical exercises will be developed. B) Patients intake: in a zoom meeting, a registered therapist (Pl) in charge of implementing the intervention will request informed consent to participate in the study, explain specifics of the intervention to each participant, and will conduct an initial assessment. C) Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum Sp02), explain the educational materials, and instruct patients on safety precautions (how to pace themselves, when to seek professional or emergency care). All participants (and immediate caregiver I necessary) will receive training: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy. Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each {including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.). The therapist will lead the first three meetings, gradually encourage participants to take turns leading the exercises with the goal of identifying /empowering potential patient leaders. Beginning with the fourth meeting, participants will be encouraged to connect to the meeting and follow their exercise program on their own, taking into account their individualized recommendations. The RA will organize and attend the zoom meetings to resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. D) Self-monitoring: patients will be asked to wear the finger pulse oximeter at all times while exercising, so that they can control their pace while avoiding exceeding target values (HR, Sp02). They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary. E) Support: participants will be able to contact the therapist at any time during the study if they have questions or concerns. Otherwise, they will receive a follow-up phone call once a week from the RA.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ、R3E 0T6
- U of Manitoba
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Clinical diagnosis of interstitial lung disease
- Access to a smart phone or tablet and home internet
Exclusion Criteria:
- Acute exacerbation of their ILDs condition
- History of neurological disease or mental illness
- Inability to ambulate independently without supervision
- Inability to complete basic tasks on a smart phone or tablet
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
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実験的:少人数でのzoomミーティング
グループ 1: 週に 3 回、各 45 分 (無料でミーティングの前の 5 分と後の 10 分を含む) のズーム ミーティングで、仲間の小さなグループ (2 グループ/各 6 人の参加者) と一緒に運動プログラムに従うように求められます。参加者間のトークチャット。
質問、認識など)。
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Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g.
maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.
All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.
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実験的:YouTube の事前録画ビデオ
グループ 2: 事前に録画された YouTube ビデオを見ながら、1 週間に 3 回、各 30 分のエクササイズ プログラムに従うよう求められます。
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Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g.
maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.
All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.
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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 |
|---|---|---|
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肺活量の変化
時間枠:8週間
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これは、SpiroBank Smart F/V マルチパラメータースパイロメーター (MIR) を使用して、介入前と介入の間に週に 1 回評価され、変化を監視します。
このポータブルスパイロメーターは MDSAP 承認済みで、ATS/ERS ガイドラインに準拠しており、Bluetooth 経由で iOS および Android 互換アプリ (MIR Spirobank) に自動的に接続します。
スマートフォンのメッセージとアニメーションを通じてリアルタイムのフィードバックを提供し、テスト中の個人のコンプライアンスを向上させます。
アプリは、肺活量の 19 のパラメーターに関する情報を含むテスト結果の PDF プリントアウトを生成できます。
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8週間
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疲労の変化
時間枠:8週間
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疲労重症度スケール(0~7「高いほど悪い」)は、疲労の重症度を測定するために使用されます。
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8週間
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運動能力の変化
時間枠:8週間
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1 分間の立位テスト (1 分間にタスクを完了することができる回数) で評価されます。
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8週間
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運動後の飽和状態の変化
時間枠:8週間
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SpO2 は、1 分間の立位テストの前後にデジタル指先パルスオキシメータを使用して測定されます。
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8週間
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Change in dyspnea
時間枠:8 weeks
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Modified Borg Scale (0 "none" to 10 "maximum") will be used to assess dyspnea.
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8 weeks
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Change in physical function
時間枠:8 weeks
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Assessed using the EQ-5D-5L scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better function).
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8 weeks
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Changes in health-related quality of life (HRQoL)
時間枠:8 weeks
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Assessed with the King's Brief Interstitial Lung Disease (KBILD), which is an ILD-specific measure of HRQoL.
Total score ranges are 0-100 (100 represents best HRQoL).
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8 weeks
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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