Cognitive FrailtyPCDSNCT07335978
Chair Exercise and Intergenerational Activities in Older Adults With Physio-Cognitive Decline Syndrome
A study testing Intervention 1 in people with Cognitive Frailty, run by Atma Jaya Catholic University of Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Frailty
- What is being tested?
- Intervention 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 24 Sep 2025to 16 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
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
About this study
Official 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
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
Read more
- 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
Read the 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.
- Conditions
- Cognitive Frailty
- Being tested
- Intervention 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from baseline to week 16
Secondary outcomes (5)
Hand grip strength
Change in hand grip strength (in kilogram; dominant hand, best of 3 trials using hand dynamometer) from baseline to week 16.
Measured: 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.
Measured: baseline to week 16
Cognitive Function
Change in cognitive function (MoCA-Ina total score, range 0-30)
Measured: from baseline to week 16
health-related quality of life (SF-12 questionnaire)
Change in health-related quality of life (SF-12 questionnaire)
Measured: 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.
Measured: baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start24 Sep 2025
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atma Jaya Catholic University of Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Rensa, Atma Jaya Catholic University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335978
- Sponsor's protocol ID
- 25-06-0948
- Acronym
- PCDS
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07335978
- Acronym / sponsor ID
- PCDS / 25-06-0948
- Conditions
- Cognitive Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atma Jaya Catholic University of IndonesiaUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Intervention 1Nutritional 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) |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1Nutritional 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). | Behavioural | Intervention Arm |
Primary outcome
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.
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.
5 secondary outcomes
Hand grip strength
Time frame: from baseline to week 16
Gait Speed Test
Time frame: baseline to week 16
Cognitive Function
Time frame: from baseline to week 16
health-related quality of life (SF-12 questionnaire)
Time frame: from baseline to week 16
serum mBDNF levels
Time frame: baseline to week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Cognitive Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Recruiting
Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty
Oral Frailty, Mild Cognitive Impairment (MCI)
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Recruiting
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Frailty at Older Adults, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 in people with Cognitive Frailty, run by Atma Jaya Catholic University of Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Syndrome Status (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.