NCT06135740

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

November 13, 2023

Last Update Submit

April 13, 2026

Conditions

Cognition Disorders in Old AgeCognitive FunctionFrailty/SarcopeniaMCI

Outcome Measures

Primary Outcomes (3)

  • Executive function

    TMT

    0 - 6 months

  • General Cognition

    MoCA

    0 - 6 months

  • Muscle mass

    Skeletal Muscle mass Index

    0 - 6 months

Secondary Outcomes (2)

  • Amount of exercise

    0 - 6 months

  • Amount of sleep

    0 - 6 months

Other Outcomes (2)

  • Frail/Sarcopenia

    0 - 6 months

  • Malnutrition

    0 - 6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data

Device: Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data

Control

SHAM COMPARATOR

Regular Care

Device: Routine care

Interventions

Fitbit wearing, with notification for sleep, activity and nutrition based fitbit dataDEVICE

Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data, and Nutritional supplementation and Promotion of Exercise

Intervention
Routine careDEVICE

Regular Care on sleep, activity and nutrition

Control

Eligibility Criteria

Age65 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Frontier Sciences, The University of Tokyo

Kashiwa, Chiba, 2778562, Japan

Location

MeSH Terms

Conditions

FrailtySarcopenia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Tatsuhiro Hisatsune, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

November 8, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

JP(1)