Test degli interventi per la mobilità attraverso l'esercizio (TIME) (TIME)
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
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
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
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State College of Medicine
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / 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
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
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
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
Sponsor
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello 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
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .