NCT07335978

Brief Summary

The goal of this clinical trial is to investigate the effects of chair exercise followed by intergenerational activity in frailty syndrome and changes in serum mBDN levels among older adults with Physio-Cognitive Decline Syndrome (PCDS), as a novel approach integrating physical and social intervention with biomolecular assessments In older adults with PCDS

  • Weeks 1-2: once weekly
  • Weeks 3-6: twice weekly
  • Week 7-12: three times weekly Additional activities include (intervention and control group):
  • Weeks 1 and 11: teleconference session on nutrition and physical exercise supported by electronic flyers (e-flyers).
  • Weeks 3, 5, 7, 11, and 13: distribution of e-flyers on elderly nutrition and the muscle-brain axis. Additional Activity (intervention group) \- Weeks 13-16: intergenerational activities at an orphanage with children aged \>5 years Assessments (intervention and control group):
  • Week 1: serum mBDNF and HbA1c measurement
  • Week 12 and 16: physical assessments (body weight, height, handgrip strength, gait speed, MoCA-Ina, and IADL) and serum mBDNF measurement. Control Group: The participant will receive general health education on performing physical exercise 1-3 times per week throughout week 1-16

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Frailty Syndrome Status

    • Change in frailty syndrome status (assessed using Cardiovascular Health Study criteria: score 0 robust, 1-2 pre-frail, ≥3 frail) from baseline to week 16.

    From enrollment to the end of treatment at 12 weeks

  • serum mature brain-derived neurotrophic factor (mBDNF)

    Change in serum mature brain-derived neurotrophic factor (mBDNF) levels (measured by ELISA) from baseline to week 16.

    from baseline to week 16

Secondary Outcomes (5)

  • Hand grip strength

    from baseline to week 16

  • Gait Speed Test

    baseline to week 16

  • Cognitive Function

    from baseline to week 16

  • health-related quality of life (SF-12 questionnaire)

    from baseline to week 16

  • serum mBDNF levels

    baseline to week 16

Other Outcomes (7)

  • Adherence to exercise sessions

    from baseline to week 12

  • Intergenerational activities

    from weeks 13 to weeks 16

  • Physical Activity Scale for the Elderly, PASE

    from baseline to week 16

  • +4 more other outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Nutritional education + 12 weeks structured chair-based exercise (PEROSI protocol, progressive frequency from 1 to 3 sessions/week, 60 minutes/session, supervised online) followed sequentially by 4 weeks SHP-based intergenerational activities (8 sessions, 2x/week, 45 minutes/session, paired 1:1 elderly-child using AMIR educational materials at selected orphanages).

Behavioral: Intervention 1

Control Arm

NO INTERVENTION

Nutritional education only (2 personalized dietitian tele-conferences at weeks 1 and 11; 5 educational e-flyers at weeks 3, 5, 7, 13, and 15)

Interventions

Intervention 1BEHAVIORAL

Nutritional education + 12 weeks structured chair-based exercise (PEROSI protocol, progressive frequency from 1 to 3 sessions/week, 60 minutes/session, supervised online) followed sequentially by 4 weeks SHP-based intergenerational activities (8 sessions, 2x/week, 45 minutes/session, paired 1:1 elderly-child using AMIR educational materials at selected orphanages).

Intervention Arm

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Aged 60-75 years * Meet diagnostic criteria for physio-cognitive decline syndrome (PCDS): gait speed \<1.0 m/s and/or hand grip strength \<28 kg (men) or \<18 kg (women), and MoCA-Ina score 22-26 * Instrumental Activities of Daily Living (IADL) score \>5 * Able to understand and follow instructions adequately * Willing to participate and provide written informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Catholic Church of St. Anthony of Padua, Bidaracina, GKI Depok, Catholic Church of St. Anna, Catholic Chrusch St. Aloysius Gonzaga

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princial Investigator

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

September 24, 2025

Primary Completion

March 16, 2026

Study Completion

March 16, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations