Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 2
Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults
The purpose of this research is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.
調査の概要
状態
条件
詳細な説明
Study 2 is an open-label, randomized, parallel-group controlled pilot trial. Participants will be randomized in a 1:1 ratio to eight weeks of supervised We Innovate Mobility (WIM)-assisted treadmill walking or conventional treadmill walking. Exercise intensity will be prescribed using a target of 70% heart rate reserve, with speed and grade adjusted to maintain walking intensity. Outcomes will be assessed before and after the intervention.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kim Kennedy
- 電話番号：336.713.8567
- メール：kimberly.kennedy@advocatehealth.org
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Atrium Health Wake Forest Baptist
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コンタクト：
- Kim Kennedy
- 電話番号：336-713-8567
- メール：kimberly.kennedy@advocatehealth.org
-
-
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:
- Community-dwelling adult aged ≥65 years
- Able to safely wear and use the WIM device
- Willing to complete conventional and WIM-assisted treadmill walking
- Able to provide informed consent and comply with study procedures
- Able to provide informed consent and comply with study procedures
Exclusion Criteria:
- Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking
- Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise
- Requires a cane, walker, or other assistive device for ambulation
- Regular participation in structured aerobic exercise
- Any condition judged by the study clinician to make participation unsafe or interfere with study procedures
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：支持療法
- 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：We Innovate Mobility (WIM)-Assisted Treadmill Walking
participants will walk on treadmill with assistance from the We Innovate Mobility (WIM) device |
We Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill three times per week for eight weeks while wearing the device. |
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アクティブコンパレータ：Conventional Treadmill Walking
participants will walk on treadmill without assistance from the We Innovate Mobility (WIM) device |
Participants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device. |
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 Peak Oxygen Consumption
時間枠：From baseline to week 8
|
Change in peak oxygen consumption (VO2peak) |
From baseline to week 8
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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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Exercise Dose
時間枠：Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
Exercise dose is defined was walking duration x average treadmill speed x average treadmill grade |
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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400 Meter Walk Time
時間枠：Baseline and Week 8
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Participants will be instructed to walk 400 meters at their usual fast pace without running, with standardized encouragement provided throughout the test. Participants will be permitted to slow down or rest briefly if needed for safety. Total completion time recorded. Participants will be permitted to slow down or rest briefly if needed for safety. |
Baseline and Week 8
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Expanded Short Physical Performance Battery (eSPPB)
時間枠：Baseline and Week 8
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eSPPB consists of 5 repeated chair stands, standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 6-meter walk to assess usual gait speed, and a narrow 6-meter walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). Total score range is 0-4 with a higher score indicating better performance. |
Baseline and Week 8
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PROMIS Fatigue Short Form 7a Survey
時間枠：Baseline and Week 8
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PROMIS Fatigue Short Form 7a measures the severity and functional impact of fatigue on everyday functioning. Total score range is 7-35 with a higher score indicating a higher level of fatigue. |
Baseline and Week 8
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Pittsburgh Fatigability Scale
時間枠：Baseline and Week 8
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Activity-related fatigability will be assessed using the Pittsburgh Fatigability Scale which evaluates perceived physical fatigue in response to standardized daily activities of defined intensity and duration. Total score range is 0-50 with higher numbers representing greater perceived fatigability. |
Baseline and Week 8
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Oxygen Consumption Rate
時間枠：Baseline and Week 8
|
Oxygen consumption rate of the peripheral blood mononuclear cells (PBMC) cells measured using respirometry. |
Baseline and Week 8
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協力者と研究者
捜査官
- 主任研究者：Bumsoo Ahn, PhD、Atrium Health Wake Forest Baptist
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- IRB00157231.2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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