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Test degli interventi per la mobilità attraverso l'esercizio (TIME) (TIME)

1 ottobre 2026 aggiornato da: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

PCORI-HA-2021C3-25041 Efficacia comparativa di brevi esercizi di forza ed equilibrio e esercizi di gruppo standard da casa per pazienti di cure primarie con disabilità motoria

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

702

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Pennsylvania
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • Penn State College of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Sperimentale: 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

Comparatore attivo: 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

Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical Function
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Lower Extremity Performance
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 12 Months

Upper and lower extremity strength

12 Months
Walking Ability
Lasso di tempo: 12 Months

6 Minute Walk Distance

12 Months
Fatigue, Pain
Lasso di tempo: 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
Lasso di tempo: 12 Months

Percent experiencing a fall-related injury

12 Months
Physical Activity
Lasso di tempo: 12 months

Accelerometry over 7 days

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

Injuries due to physical activities

Monthly up to 12 months
Program Satisfaction
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Weight (kg)
Lasso di tempo: 12 Months

Body Weight (kg)

12 Months
Height (cm)
Lasso di tempo: 12 Months

Height (cm)

12 Months
Sociodemographics, self-reported medical history and tobacco use
Lasso di tempo: Baseline

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

Baseline
Caregiving Status Questions (Receiving and Providing)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 luglio 2023

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

12 gennaio 2023

Primo inviato che soddisfa i criteri di controllo qualità

2 febbraio 2023

Primo Inserito (Effettivo)

13 febbraio 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • HA-2021C3-25041
  • PCORI-HA-2021C3-25041 (Altro identificatore: PCORI)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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