運動による可動性のための介入のテスト (TIME) (TIME)
PCORI-HA-2021C3-25041 運動障害のあるプライマリケア患者に対する簡単な筋力とバランスのエクササイズと標準的な在宅グループエクササイズの効果の比較
In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.
調査の概要
状態
条件
詳細な説明
One in four older adults, the fastest growing demographic group in the US, reports serious difficulty walking or climbing stairs. Older adults note that these walking difficulties "deprives you of your identity" and "affects my day to day life… I can't do very much work on my own." Walking difficulties impair people's quality of life more than depression, anxiety, or pain. Walking difficulties also increase the chances of future disability, death, and healthcare costs. Though strength training improves walking ability, fewer than one in five older adults do strength training enough to benefit. What is unknown is how to create a strength training program that improves the ability of older adults to walk and do other things they need and want to do and that older adults are willing to do.
One approach to designing a strength training program that has not been tried before is to make them shorter. In 2020, the project team set out to design a short strength training program that older adults could do at home that would improve their physical function and that they would consistently do. The program was called FAST (Functional Activity Strength Training) and, to make it more effective, the team set specific goals for how many additional repetitions each person should be able to do over 12 weeks. These goals were then mentioned repeatedly, and feedback was provided about how well people made progress toward these goals.
In the first study of FAST (FAST-1), 24 healthy older adults performed 30 seconds of squats and push-ups each day but received no personal supervision. Over six months, they performed the exercises on 73 percent of days, which led to large increases in the number of push-ups and squats they were able to do. In the second study of FAST (FAST-2), the team randomly assigned 97 older adults who had trouble walking, and those assigned to do 30 seconds each of chair stands and steps onto a stepper each day improved their ability to stand up from a chair and stand on one leg more than those who did not do the exercises.
In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.
This study will enroll 520 primary care patients who are at least 65 years of age and randomly assign them to have access to 12 months of daily FAST or three-times weekly BAND TOGETHER. Each program will be delivered via the internet and each patient will receive about 30 minutes per month of personal support. The study will enroll patients who have trouble walking, have access to the internet, can provide informed consent, and receive permission from their doctor. The study is designed to see whether patients who have access to FAST, after 12 months, have better walking ability, balance, and leg strength and can do their normal daily activities more easily and fall less often than patients who have access to BAND TOGETHER.
To help us understand how best to perform the study, as well as how best to share the results, the study team assembled a group of stakeholders that includes patients, primary care providers, fitness center directors, and people who work for insurance, public health, and senior services organizations. The team will bring those stakeholders together each year and consult them regularly to help make difficult decisions as they arise-decisions that may impact each group of stakeholders differently. Two patient partners will work with investigators to supervise the group of stakeholders and organize their feedback, structured as a public comment period, to help the research team make decisions that take into account the perspectives of all of the key groups of stakeholders involved in improving the physical function of older adults.
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
-
-
Pennsylvania
-
Hershey、Pennsylvania、アメリカ、17033
- Penn State College of 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:
- Age greater than or equal to 65
- Self reported difficulty or inability to walk 1/4/ mile
- Access to the Internet
- Covid vaccination
Exclusion Criteria:
- Chest pain on the PAR-Q
- Participating in another research project involving physical activity, falls or weight loss
- Planning to move or have surgery in the next 12 months
- Cognitive impairment
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 |
|---|---|
|
実験的:FAST-BCT
FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching. |
Daily exercise intervention including functional resistance exercises and personalized coaching. |
|
実験的:FAST+BCT
FAST exercise intervention with behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort. |
Daily exercise intervention including functional resistance exercises and personalized coaching. Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence |
|
アクティブコンパレータ:BT-BCT
Band Together exercise intervention without behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes. |
3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes |
|
アクティブコンパレータ:BT+BCT
Band Together exercise intervention with behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort. |
Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence 3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes |
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 |
|---|---|---|
|
Physical Function
時間枠:12 Months
|
Patient-Reported Outcomes Measurement Scale (PROMIS-29). The minimum and maximum values are unable to do and without any difficulty, and a higher score means a better outcome. |
12 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lower Extremity Performance
時間枠:12 Months
|
Short Physical Performance Battery. The minimum value is a score of 0 points, the maximum value is a score of 16. A higher score means a better outcome. |
12 Months
|
|
Dose Received
時間枠:Through study completion, an average of 1 year
|
Sessions completed per week (percent) |
Through study completion, an average of 1 year
|
|
Effort (Rating of Perceived Exertion)
時間枠:Monthly up to 12 months
|
Rating of Perceived Exertion. The minimum value is 0 (at rest) and the maximum value is 10 (maximal). This is a purely subjective measure here a higher or lower score doesn't necessarily lead to a better outcome, but for our exercise study we have a target RPE of 5 for exercise. |
Monthly up to 12 months
|
|
Gait Speed (10 meter walk test)
時間枠:12 Months
|
Gait Speed (10 meter walk test). Participants undergo two trials (comfortable speed and fast speed), and an average of the two trials is used as the gait speed in m/s. |
12 Months
|
|
Muscle Strength
時間枠:12 Months
|
Upper and lower extremity strength |
12 Months
|
|
Walking Ability
時間枠:12 Months
|
6 Minute Walk Distance |
12 Months
|
|
Fatigue, Pain
時間枠:12 Months
|
Patient Reported Outcomes Measurement Scale (PROMIS-29). The minimum value for the fatigue scales is "not at all", the maximum value is "very much". A lower score means a better outcome. The minimum values for the pain scales are "not at all" and 0, the maximum values "very much" and 10. A lower value means a better outcome. |
12 Months
|
|
Falls
時間枠:12 Months
|
Percent experiencing a fall-related injury |
12 Months
|
|
Physical Activity
時間枠:12 months
|
Accelerometry over 7 days |
12 months
|
|
Number of participants with a self-reported injury due to physical activities
時間枠:Monthly up to 12 months
|
Injuries due to physical activities |
Monthly up to 12 months
|
|
Program Satisfaction
時間枠:Monthly up to 12 months
|
Net Promoter Score. The maximum value is 10 and the minimum value is 0. A higher value means a better outcome. |
Monthly up to 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Weight (kg)
時間枠:12 Months
|
Body Weight (kg) |
12 Months
|
|
Height (cm)
時間枠:12 Months
|
Height (cm) |
12 Months
|
|
Sociodemographics, self-reported medical history and tobacco use
時間枠:Baseline
|
Age, gender, race and ethnicity, medical history, smoking status, and education |
Baseline
|
|
Caregiving Status Questions (Receiving and Providing)
時間枠:Monthly up to 12 months
|
Giving and receiving caregiving, paid or unpaid, for personal care needs, such as eating, bathing, dressing, or getting around inside the home. |
Monthly up to 12 months
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- HA-2021C3-25041
- PCORI-HA-2021C3-25041 (その他の識別子:PCORI)
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
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