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Completed

NCT Number: NCT07335978

Chair Exercise and Intergenerational Activities in Older Adults With Physio-Cognitive Decline Syndrome

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

1. 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? 2. Does a 16-week program of chair exercise followed by an intergenerational activity increase serum mBDNF level? 3. 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

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Key information

Conditions

Cognitive Frailty

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Cognitive Function

    Time frame: from baseline to week 16

    Change in cognitive function (MoCA-Ina total score, range 0-30)

  4. 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)

  5. 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.

Other outcomes

  1. Adherence to exercise sessions

    Time frame: from baseline to week 12

    Adherence to exercise sessions

  2. Intergenerational activities

    Time frame: from weeks 13 to weeks 16

    Adherence to intergenerational activities (attendance logs)

  3. 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

  4. 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:

    • 0 - 4: Normal
    • 5 - 10: Mild to moderate depression
    • 11 - 15: Severe Depression

  5. 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)

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Atma Jaya Catholic University of Indonesia

Other

Registry information

Official study title

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

Acronym: PCDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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