Digital Support for Supervised Exercise Therapy in Peripheral Arterial Disease (TrackPAD)
Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Randomized Controlled Pilot Trial.
The individual restrictions of daily life for patients with PAD are more important than statistical facts for mortality and morbidity. Intermittent claudication causes a progressive reduction of the pain-free walking distance (PWD) as an expression of a worsening PAD. This decrease in physical capability results in a decline of mental health and relevantly reduces the patients' quality of life (QoL).
Supervised exercise therapy (SET) is a cornerstone in the conservative management of intermittent claudication and extends the PWD. Even though SET is easy to practice and highly cost effective, the adherence to perform SET on a regular base is rather low. The underuse of exercise can be partly explained by the lack of institutional resources, but also by both patients' and physicians' lack of interest in exercise.
Mobile health (mHealth) technologies increase the incentives and provide digital support for patients with PAD on several treatment levels. They might lead to a higher adherence to exercise training and offer new scopes in patient-centered healthcare, but so far studies show opposite results. Because app stores are flooded with health and fitness apps, specific support tools are highly desired by patients with PAD and PAD-specific solutions are missing so far. Based on this background, the investigators developed a smartphone app named TrackPAD to provide PAD-specific support for SET.
The TrackPAD pilot study was designed as a 2-armed randomized controlled trial and included patients with diagnosed and symptomatic PAD. Patients were randomized by the Center for Clinical Studies in Essen using the TENALEA software into 2 groups. The control group included participants with standard care and no further mobile intervention. The intervention group included participants with standard care and additional mHealth-based self-tracking of their physical activity using trackPAD.
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
-
-
-
Essen、ドイツ、45147
- Department of Cardiology and Vascular Medicine
-
-
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:
Diagnosis of lower extremity PAD based on (and/or):
- ABI ≤ 0.9 in at least one legs
- Invasive or non-invasive imaging of stenotic lower extremity artery disease
- Endovascular or surgical revascularization of lower extremity artery
- PAD Fontaine Stage IIa/b
- Smartphone with possibility to use TrackPAD: Android ≥ 5.0 or IOS ≥ 11.0
- Written informed consent prior to any study procedures, including a specified follow-up evaluation
- Best-medical treatment in the last 2 months in accordance with standard guidelines
Exclusion Criteria:
- Wheelchair bound, use of walking aid or walking impairment due to another cause than PAD
- Below or above knee amputation
- Acute or critical limb ischemia
- PAD Fontaine Stage I or III / IV
- No German knowledge
- Severe cognitive dysfunction
- Congestive heart failure with NYHA III-IV symptoms
- Active congestive heart failure requiring the initiation or uptitration of diuretic therapy
- Angina pectoris with CCS class 3-4 symptoms or myocardial infarction or stroke in the last 3 months
- Active arrhythmia requiring the initiation or uptitration of anti-arrhythmic therapy
- Severe valve disease
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：intervention group
in addition to the usual therapy, the patients were given access to the trackPAD app
|
TrackPAD is a smartphone app to provide PAD-specific support for SET
|
|
介入なし：control group
patients in this group were treated as usual in the clinic without additional interventions.
|
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 |
|---|---|---|
|
change in 6-minutes walking distance
時間枠：baseline, 3 months follow-up
|
measured via GPS with the trackPAD app
|
baseline, 3 months follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in physical activity, measured in patients' self-report on how many days a week on average they engage in a physical activity that causes them to sweat or get out of breath, and how many minutes on average they spend doing it.
時間枠：baseline, 3 months follow-up
|
to compare the two groups groups in terms of physical endurance, the self-reported physical activity was recorded
|
baseline, 3 months follow-up
|
|
peripheral arterial disease-related quality of life
時間枠：baseline, 3 months follow-up
|
measured with the Peripheral artery disease Quality of Life Questionnaire (PADQOL) questionnaire, a validated PAD-specific questionnaire.
Minimum score is 38 and maximum is 228, with higher values indicating a better outcome.
|
baseline, 3 months follow-up
|
|
Usability of the TrackPAD app
時間枠：baseline, 3 months follow-up
|
measured with the User version of the Mobile Application Rating Scale (uMars) questionnaire.
The uMARS includes 3 factors, namely app quality, app subjective quality and perceived impact.
Minimum score of the app quality scale is 4 and the maximum is 20.
The App Subjective Quality scale has a minimum of 4 and a maximum of 20, and the Perceived Impact scale has a minimum of 6 and a maximum of 30.
Higher values indicate a better outcome.
|
baseline, 3 months follow-up
|
協力者と研究者
捜査官
- 主任研究者：Julia Lortz、University Hospital, Essen
出版物と役立つリンク
一般刊行物
- Paldan K, Simanovski J, Ullrich G, Steinmetz M, Rammos C, Janosi RA, Moebus S, Rassaf T, Lortz J. Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2019 Jun 26;8(6):e13651. doi: 10.2196/13651.
- Paldan K, Steinmetz M, Simanovski J, Rammos C, Ullrich G, Janosi RA, Moebus S, Rassaf T, Lortz J. Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 16;9(8):e24214. doi: 10.2196/24214.
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
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。
末梢動脈疾患の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ