Status:
UNKNOWN
Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults
Lead Sponsor:
Tokyo University
Collaborating Sponsors:
Google LLC.
Conditions:
Cognition Disorders in Old Age
Cognitive Function
Eligibility:
All Genders
65-92 years
Phase:
NA
Brief 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 questio...
Detailed Description
This is a prospective, single site, interventional randomized control trial. The primary purpose is to treat age related health conditions. The current study is nested within an established cohort bas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06135740
Start Date
November 8 2023
End Date
December 31 2024
Last Update
December 5 2023
Active Locations (1)
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1
Graduate School of Frontier Sciences, The University of Tokyo
Kashiwa, Chiba, Japan, 2778562