Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Old… (NCT06135740) | Clinical Trial Compass
CompletedNot Applicable
Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults
Japan355 participantsStarted 2023-11-08
Plain-language summary
The goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. The main question of the study is to answer the effectiveness of notification on activity, sleep, and nutrition based on wearable device Fitbit recorded data for the improvement of health conditions including intellectual property and physical function, compared to usual care. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. The study intervention will run for 6 months. Notifications will be issued using a monitoring software in Japanese, and issued automatically to participants. Participants in the control arm will be given a routine care and health-related information. Researchers will compare cognitive performance, muscle mass and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults.
Who can participate
Age range
65 Years – 92 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Over 65 years of age.
* Living in Japan.
* Living independently with or without carer support.
* Able and willing to wear a Fitbit for the duration of the study (≥20 hours a day, including during sleep).
* Individuals that are able and willing to receive and act on interventions.
* Has capacity to consent to inclusion in the study.
* Smartphone access to allow Fitbit installation and setup.
* Has one or more of the following comorbidities:
* BMI \<20 (65-69 years), \<21.5 (≥70 years)
* Pre-frail or Frail: scoring 1-2 (pre-frail) or 3+ (frail) based on the FRAIL questionnaire
* Sarcopenia: low grip strength (female \<18 kg, male \<28 kg); Gait speed (\< 1m/s); low Skeletal Muscle mass Index (female 5.7 kg/m2; male 7 kg/m2)
Exclusion Criteria:
* Individuals receiving full time care in a care facility.
* Individuals that are unable to receive and/or act on interventions.
* Individuals who are existing wearable users, or who have prior experience using a wearable to manage their health.
* Individuals with uncontrolled hypertension, diabetes, CKD or with cardiac pacemakers and/or cardiovascular stent(s).
* Individuals who have any additional condition or situation that the Investigator (PI) or designee determines as inappropriate for participation in this study.
* Individuals with no comorbidities as defined above.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.