- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335978
Chair Exercise and Intergenerational Activities in Older Adults With Physio-Cognitive Decline Syndrome (PCDS)
The Role of Chair Exercise and Intergenerational Activities in Older Adults With Physico-Cognitive Decline Syndrome: An Investigation of Frailty and Serum Mature Brain-Dervied Neurotrophic Factor Level
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
- Does A 16-week program of chair exercise followed by intergenerational activity improve handgrip strength (HGS), gait speed, MoCA-Ina scores, and health-related quality of life?
- Does a 16-week program of chair exercise followed by an intergenerational activity increase serum mBDNF level?
- Are serum mBDNF levels associated with MoCA-Ina scores, gait speed, and handgrip strength?
Intervention Group
Participants will undergo a 12-week structured chair exercise program, conducted with a trained exercise instructor and supervised by a physician for vital sign monitoring during each session. The frequency of sessions will increase progressively:
- 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
Study Overview
Detailed Description
Population aging in Indonesia has led to a growing proportion of older adults experiencing functional and cognitive decline. Physio-cognitive decline syndrome (PCDS), defined as the coexistence of reduced physical performance (such as slow gait speed or weak handgrip strength) and mild cognitive impairment without disability or dementia, is considered an early and reversible stage that increases the risk of frailty, disability, and poor quality of life.
Chair exercise provides a safe and feasible intervention for older adults, with proven benefits in muscle strength, balance, and neurocognitive function, partly mediated through increased levels of brain-derived neurotrophic factor (BDNF). In parallel, an intergenerational activity involving direct interaction between older and younger individuals has shown promise in improving psychosocial well-being and cognitive outcomes.
This study integrates chair exercise with intergenerational activities to target the multidimensional nature of PCDS. Outcomes will focus on frailty status and changes in serum mature brain-derived neurotrophic factor (mBDNF) to establish a multimodal, culturally adapted strategy to support healthy aging in Indonesian older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jakarta Special Capital Region
-
Jakarta, Jakarta Special Capital Region, Indonesia
- Catholic Church of St. Anthony of Padua, Bidaracina, GKI Depok, Catholic Church of St. Anna, Catholic Chrusch St. Aloysius Gonzaga
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
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).
|
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).
|
|
No Intervention: Control Arm
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty Syndrome Status
Time Frame: From enrollment to the end of treatment at 12 weeks
|
• 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)
Time Frame: from baseline to week 16
|
Change in serum mature brain-derived neurotrophic factor (mBDNF) levels (measured by ELISA) from baseline to week 16.
|
from baseline to week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength
Time Frame: from baseline to week 16
|
Change in hand grip strength (in kilogram; dominant hand, best of 3 trials using hand dynamometer) from baseline to week 16.
|
from baseline to week 16
|
|
Gait Speed Test
Time Frame: baseline to week 16
|
Change in gait speed (m/s; average of 2 trials over 6-meter walk test) from baseline to week 16.
|
baseline to week 16
|
|
Cognitive Function
Time Frame: from baseline to week 16
|
Change in cognitive function (MoCA-Ina total score, range 0-30)
|
from baseline to week 16
|
|
health-related quality of life (SF-12 questionnaire)
Time Frame: from baseline to week 16
|
Change in health-related quality of life (SF-12 questionnaire)
|
from baseline to week 16
|
|
serum mBDNF levels
Time Frame: baseline to week 16
|
Correlations between changes in serum mBDNF levels and changes in MoCA-Ina score, hand grip strength, and gait speed.
|
baseline to week 16
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to exercise sessions
Time Frame: from baseline to week 12
|
Adherence to exercise sessions
|
from baseline to week 12
|
|
Intergenerational activities
Time Frame: from weeks 13 to weeks 16
|
Adherence to intergenerational activities (attendance logs)
|
from weeks 13 to weeks 16
|
|
Physical Activity Scale for the Elderly, PASE
Time Frame: from baseline to week 16
|
Physical activity level (Physical Activity Scale for the Elderly, PASE) is an easily administered and scored instrument that measures the level of physical activity in individuals aged 65 years and older. PASE Scored may range from zero to 400 or more |
from baseline to week 16
|
|
Depressive Symptoms
Time Frame: from baseline to week 16
|
The Geriatric Depression Scale-15 (GDS-15) is a widely used, self-report screening tool designed identify depression in older adults. The 15-item version (GDS-15) is common, and Patients answer "yes" or "no" to 15 questions regarding how they felt over the past week. Interpretation:
|
from baseline to week 16
|
|
Loneliness
Time Frame: From baseline to weeks 16
|
The questionnaire of De Jong Gierveld Loneliness Scale, Indonesian version is a concise tool designed to capture both emotional and social dimensions of loneliness.
The total loneliness score can be categorized into four levels: not lonely (Score 0, 1 or 2), moderate lonely (score 3 through 8), severe lonely (score 9 or 10), and very severe lonely (score 11)
|
From baseline to weeks 16
|
|
Quality of Life Additional Domains
Time Frame: from baseline to week 16
|
Questionnaire of Quality of life additional domains (EQ-5D-5L) is a brief, multiattribute, generic, health status measure composed 5 questions with likert response options (descriptive system).
EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
|
from baseline to week 16
|
|
Charison Comorbidity Index (CCI)
Time Frame: baseline
|
The questionnaire of the Charlson Comorbidity Index (CCI) predicts the mortality for a patient who may have a range of concurrent conditions (comorbidities), such as heart disease, AIDS, or cancer (considering a total of 17 categories).
Based on the CCI scores, the severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2, moderate, with CCI scores of 3-4, and severe, with CCI scores ≥5
|
baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 25-06-0948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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