An interventional study of Intervention 1 in Cognitive Frailty, sponsored by Atma Jaya Catholic University of Indonesia. Completed at 1 site in Indonesia. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Atma Jaya Catholic University of Indonesia · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Atma Jaya Catholic University of Indonesia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
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)
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).
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.
Time frame: 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.
Time frame: from baseline to week 16
Hand grip strength
Change in hand grip strength (in kilogram; dominant hand, best of 3 trials using hand dynamometer) from baseline to week 16.
Time frame: 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.
Time frame: baseline to week 16
Cognitive Function
Change in cognitive function (MoCA-Ina total score, range 0-30)
Time frame: from baseline to week 16
health-related quality of life (SF-12 questionnaire)
Change in health-related quality of life (SF-12 questionnaire)
Time frame: 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.
Time frame: baseline to week 16
Adherence to exercise sessions
Adherence to exercise sessions
Time frame: from baseline to week 12
Intergenerational activities
Adherence to intergenerational activities (attendance logs)
Time frame: 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
Time frame: 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: 1. 0 - 4: Normal 2. 5 - 10: Mild to moderate depression 3. 11 - 15: Severe Depression
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: baseline
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