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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
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:
Additional activities include (intervention and control group):
Additional Activity (intervention group)
- Weeks 13-16: intergenerational activities at an orphanage with children aged >5 years
Assessments (intervention and control group):
Control Group:
The participant will receive general health education on performing physical exercise 1-3 times per week throughout week 1-16
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hand grip strength | 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 | Change in gait speed (m/s; average of 2 trials over 6-meter walk test) from baseline to week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to exercise sessions | Adherence to exercise sessions | from baseline to week 12 |
| Intergenerational activities | Adherence to intergenerational activities (attendance logs) |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2025 | Jan 2, 2026 | Prot_SAP_000.pdf |
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|
| baseline to week 16 |
| Cognitive Function | Change in cognitive function (MoCA-Ina total score, range 0-30) | from baseline to week 16 |
| health-related quality of life (SF-12 questionnaire) | Change in health-related quality of life (SF-12 questionnaire) | from baseline to week 16 |
| serum mBDNF levels | Correlations between changes in serum mBDNF levels and changes in MoCA-Ina score, hand grip strength, and gait speed. | baseline to week 16 |
| from weeks 13 to weeks 16 |
| Physical Activity Scale for the Elderly, PASE | 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 | 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 | 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 | 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) | 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 |