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運動による可動性のための介入のテスト (TIME) (TIME)

2026年10月1日 更新者:Christopher Sciamanna, MD, MPH、Milton S. Hershey Medical Center

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

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

介入

入学 (実際)

702

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Pennsylvania
      • Hershey、Pennsylvania、アメリカ、17033
        • Penn State College of Medicine

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年7月27日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2023年1月12日

QC基準を満たした最初の提出物

2023年2月2日

最初の投稿 (実際)

2023年2月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月5日

QC基準を満たした最後の更新が送信されました

2026年10月1日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

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

いいえ

米国FDA規制機器製品の研究

いいえ

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