Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
調査の概要
状態
詳細な説明
Chronic pain is a vast problem with profound consequences for individuals and societies. Exercise and physical activity is an important part of the treatment for chronic pain. Use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. Here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.
The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for personal activity Intelligence. You earn PAI points every time your heart rate increases: The higher heart rate, the faster you earn PAI. Previous research have shown that those who achieve 100 PAI or more every week over time live for an average of more than eight years longer than others.
During the study all participants will take part in a traditional inpatient rehabilitation program. The program consist of two periods at the rehabilitation center with two weeks at home in-between. The study will take place during the two periods at the senter and the period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.
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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Rissa、ノルウェー
- Unicare Helsefort
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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:
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.
Exclusion Criteria:
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：フィードバックのないウェアラブル技術
このグループは、介入グループと同じ活動測定装置を装着しますが、活動レベルに関するフィードバックは受け取りません。
モバイル アプリケーションにはアクセスできません。
彼らは、介入グループと同じリハビリテーション プログラムに参加します。
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traditional inpatient rehabilitation program.
An armwrist device measuring physical activity level, no reporting back to the user.
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実験的：Wearable tech with feedback
This group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for patients with chronic pain.
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An armwrist device measuring physical activity level.
The user will receive information about their physical activity level through their smartphone.
traditional inpatient rehabilitation program.
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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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Activity level
時間枠：2 weeks (time period at home between two stays at the rehabilitation center)
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Time spent in moderate to vigorous physical activity (minutes per day)
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2 weeks (time period at home between two stays at the rehabilitation center)
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Number of PAIs
時間枠：2 weeks (time period at home between two stays at the rehabilitation center)
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mean number of Personal Activity Intelligence (PAI) points achieved per week
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2 weeks (time period at home between two stays at the rehabilitation center)
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Percentage achieving 100 PAIs per week
時間枠：2 weeks (time period at home between two stays at the rehabilitation center)
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Personal Activity Intelligence (PAI)
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2 weeks (time period at home between two stays at the rehabilitation center)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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oxygen uptake
時間枠：6 weeks (from inclusion to end of rehabilitation program)
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submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
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6 weeks (from inclusion to end of rehabilitation program)
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Anxiety and depression symptoms
時間枠：6 weeks (from inclusion to end of rehabilitation program)
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HSCL-25 questionnaire
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6 weeks (from inclusion to end of rehabilitation program)
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Average pain
時間枠：6 weeks (from inclusion to end of rehabilitation program)
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Visual Analogue Scale (VAS).
VAS is a straight horizontal line where the ends are defined as the extreme limits from the left (0-no pain) to the right (100-worst imaginable pain).
The patient is asked to mark his pain level on the line between the two endpoints.
The distance between 'no pain at all' and the mark then defines the subject's pain.
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6 weeks (from inclusion to end of rehabilitation program)
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Health related quality of life
時間枠：6 weeks (from inclusion to end of rehabilitation program)
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EQ5D questionnaire
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6 weeks (from inclusion to end of rehabilitation program)
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Body weight
時間枠：6 weeks (from inclusion to end of rehabilitation program)
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body weight in kilograms
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6 weeks (from inclusion to end of rehabilitation program)
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Body Mass Index score
時間枠：6 weeks (from inclusion to end of rehabilitation program)
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weight in kilograms divided by height in metres squared
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6 weeks (from inclusion to end of rehabilitation program)
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協力者と研究者
捜査官
- 主任研究者：Lene Aasdahl, PhD MD、National Taiwan Normal University
- スタディディレクター：Jorunn Helbostad, Dr Philos、Norwegian University of Science and Technology
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。
筋骨格痛の臨床試験
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