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Testinterventionen für Mobilität durch Bewegung (TIME) (TIME)

1. Oktober 2026 aktualisiert von: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

PCORI-HA-2021C3-25041 Vergleichende Wirksamkeit von kurzen Kraft- und Gleichgewichtsübungen und Standard-Gruppenübungen zu Hause für Patienten in der Grundversorgung mit Mobilitätseinschränkung

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

702

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Pennsylvania
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033
        • Penn State College of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

Experimental: 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

Aktiver Komparator: 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

Aktiver Komparator: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical Function
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lower Extremity Performance
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 12 Months

Upper and lower extremity strength

12 Months
Walking Ability
Zeitfenster: 12 Months

6 Minute Walk Distance

12 Months
Fatigue, Pain
Zeitfenster: 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
Zeitfenster: 12 Months

Percent experiencing a fall-related injury

12 Months
Physical Activity
Zeitfenster: 12 months

Accelerometry over 7 days

12 months
Number of participants with a self-reported injury due to physical activities
Zeitfenster: Monthly up to 12 months

Injuries due to physical activities

Monthly up to 12 months
Program Satisfaction
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body Weight (kg)
Zeitfenster: 12 Months

Body Weight (kg)

12 Months
Height (cm)
Zeitfenster: 12 Months

Height (cm)

12 Months
Sociodemographics, self-reported medical history and tobacco use
Zeitfenster: Baseline

Age, gender, race and ethnicity, medical history, smoking status, and education

Baseline
Caregiving Status Questions (Receiving and Providing)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Juli 2023

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

12. Januar 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Februar 2023

Zuerst gepostet (Tatsächlich)

13. Februar 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HA-2021C3-25041
  • PCORI-HA-2021C3-25041 (Andere Kennung: PCORI)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .