Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
調査の概要
詳細な説明
This study presents the protocol of a prospective, single-center, single-blinded, two-armed randomized controlled trial.
The investigators plan to recruit patients over 65 years of age with degenerative knee arthritis or chronic low back pain. Patients will be randomly divided into two groups with 1:1 allocation.
The intervention group will receive 6 weeks of the IoT-based home exercise program. The IoMT-based home exercise program is implemented to the patients via a smartphone application. The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise (Figure 1). The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
The activity detector records the amount of activity and the speed of movement within the home. The door sensor detects the enter and exit and records the number of outings. The pillbox notifies subjects to take the medication time. The smart-care phone provides emergency call and guardian connection services. The body composition analyzer measures body mass index, fat, and muscle mass.
The primary outcome in patients with degenerative knee arthritis is Western Ontario and McMaster Universities Osteoarthritis. And the primary outcome in patients with chronic low back pain is Oswestry Disability Index. The secondary outcomes are numeric rating scale for pain, 36-Item Short-Form Health Survey, Geriatric Depression Scale, Timed-Up and Go test, and 30s chair sit and stand.
The investigators evaluate primary and secondary outcomes before and after the home exercise programs.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jeongyi Kwon, M.D,PhD
- 電話番号：+82-2-3410-2818
- メール：jeongyi.kwon@samsung.com
研究場所
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Seoul、大韓民国、06351
- 募集
- Samsung Medical Center
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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:
- Knee pain for more than 3months, Kellgren-Lawrence grade 2 or higher
- Low back pain for more than 3months
- A person who underdtands the exercise program
- Numeric rating scale of 4 or higher
Exclusion Criteria:
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
- Chronic obstructive pulmonary 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：ダブル
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：Home-based exercise program
The subjects will receive 6 weeks of the home exercise program via a smartphone application.
The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise.
The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
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Daily home based exercise program (30min/day, 7days/week for 6 weeks).
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介入なし：Exercise brochure
This group will be offered a brochure including number of exercises for back or knee.
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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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Western Ontario and McMaster Universities Osteoarthritis
時間枠：baseline
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Knee osteoarthritis functional index (Range: 0-96)
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baseline
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Western Ontario and McMaster Universities Osteoarthritis
時間枠：after 6weeks
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Knee osteoarthritis functional index (Range: 0-96)
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after 6weeks
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Oswestry Disability Index
時間枠：baseline
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Low back pain functional index (Range: 0-100)
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baseline
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Oswestry Disability Index
時間枠：after 6weeks
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Low back pain functional index (Range: 0-100)
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after 6weeks
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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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Numeric rating scale
時間枠：baseline
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Pain score, The higher score means the worse pain (Range: 0-10)
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baseline
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Numeric rating scale
時間枠：after 6weeks
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Pain score, The higher score means the worse pain (Range: 0-10)
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after 6weeks
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36-Item Short-Form Health Survey
時間枠：baseline
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Qualify of life, The higher score means the better condition (Range: 0-100)
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baseline
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36-Item Short-Form Health Survey
時間枠：after 6weeks
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Qualify of life, The higher score means the better condition (Range: 0-100)
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after 6weeks
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Geriatric Depression Scale
時間枠：baseline
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Depression score, The higher score means the worse condition (Range: 0-15)
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baseline
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Geriatric Depression Scale
時間枠：after 6weeks
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Depression score, The higher score means the worse condition (Range: 0-10)
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after 6weeks
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Timed-Up and Go test
時間枠：baseline
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Dynamic balance, The higher score means the worse balance.
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baseline
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Timed-Up and Go test
時間枠：after 6weeks
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Dynamic balance, The higher score means the worse balance.
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after 6weeks
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30s chair sit and stand
時間枠：baseline
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Balance, The higher score means the better condition.
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baseline
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30s chair sit and stand
時間枠：after 6weeks
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Balance, The higher score means the better condition.
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after 6weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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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