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Exercise Programs for Limited Mobility (TIME Trial)
N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
TIME Trial Summary
This trial will compare two exercises programs for older adults to see if one encourages them to be more consistent and to try harder, potentially improving leg function.
Who is the study for?
This trial is for individuals aged 65 or older who have trouble walking and can access the internet. Participants must be vaccinated against COVID-19 and not planning to move, undergo surgery, or join other physical activity research within a year. Those with chest pain during exercise or cognitive impairment cannot join.Check my eligibility
What is being tested?
The TIME trial compares two home-based exercise programs: FAST (focused on strength training) and BAND TOGETHER (similar to Silver Sneakers with strength, balance, aerobic exercises). The goal is to see if FAST leads to better leg function by promoting consistency and effort in workouts.See study design
What are the potential side effects?
While specific side effects are not listed for these interventions, general risks may include muscle soreness, fatigue from exercise, potential strain injuries from overexertion, and falls due to balance issues while exercising.
TIME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physical Function
Secondary outcome measures
Dose Received
Effort (Rating of Perceived Exertion)
Falls
+8 moreOther outcome measures
Body Weight (kg)
Caregiving Status Questions (Receiving and Providing)
Height (cm)
+1 moreTIME Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: FAST-BCTExperimental Treatment1 Intervention
FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching.
Group II: FAST+BCTExperimental Treatment2 Interventions
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.
Group III: BT+BCTActive Control2 Interventions
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.
Group IV: BT-BCTActive Control1 Intervention
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.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
495 Previous Clinical Trials
2,798,254 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I have difficulty with memory or thinking clearly.I have received the COVID vaccine.I struggle or can't walk a quarter mile.I experience chest pain.I am not planning to move or have surgery in the next year.
Research Study Groups:
This trial has the following groups:- Group 1: BT+BCT
- Group 2: FAST-BCT
- Group 3: FAST+BCT
- Group 4: BT-BCT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this trial still open?
"Affirmative. According to the information displayed on clinicaltrials.gov, this research project is currently accepting participants and was first posted in late July of 2023; it has recently been updated as well. The trial requires 620 enrollees from a single site."
Answered by AI
What is the anticipated enrollment size for this trial?
"Affirmative. On clinicaltrials.gov, it is revealed that this medical study - published on July 27th 2023 and last updated 16 days later – still actively recruits 620 patients from a single site."
Answered by AI
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