AgingNCT05309278
Remote Physical and Cognitive Training Effects in Older Adults at Increased Risk of Clinical-functional Vulnerability
A study testing Physical training and Cognitive training in people with Aging and Functional Status, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Functional Status
- What is being tested?
- Physical training and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jul 2022to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age or older,
- MMSE score equal to or greater than 19 points,
- Elementary school education complete or over,
- Sedentary (no current or previous participation in structured exercise (>1x/week) in the past 6 months),
- Increased risk of clinical-functional vulnerability, as determined by the Clinical-Functional Vulnerability Index-20 (IVCF-20) questionnaire.
- Access to a cell phone or notebook with internet access,
- Resident in the city of Pelotas, Brazil.
Who cannot join
- Individuals who have been affected by COVID-19,
- Not retired, or those retired individuals who maintained continuous or sporadic work activities,
- Neuromuscular deficits or any medical diagnosis that prevents the individuals from performing physical exercises,
- Individuals with decompensated or untreated blood pressure (> than 140x90 mmHg) and,
- Individuals with visual problems that prevent them from watching the training sessions on their cell phone or notebook screen.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola Superior de Educação Física
Pelotas, Rio Grande do Sul, 96055-630
About this study
Official title: Effects of a Remote Physical Training Program Combined With Cognitive Training in Older Adults at Increased Risk of Clinical-functional Vulnerability: a Randomized Clinical Trial
This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the self-reported quality of life.
Read the detailed description
Participants over 60 years of age at increased risk of clinical-functional vulnerability will be recruited in the city of Pelotas/RS, Brazil and randomized to two different arms. The intervention group will receive low-intensity physical training combined with a cognitive training program using neurobic exercises, whereas the active comparator group will only receive the low-intensity physical training program. Participants from both groups will perform their training sessions remotely for a total of 12 weeks. Outcomes of interest include handgrip strength, functional and cognitive capacity, occupational performance, clinical-functional vulnerability level, self-reported quality of life, and depressive symptoms, which will be assessed in a pre-post fashion. The study hypothesis is that remote low-intensity physical training combined with cognitive training will result in additional benefits to those of low-intensity physical training alone in the physical and cognitive capacity outcomes, and as a consequence, improved quality of life, occupational performance, decreased level of clinical-functional vulnerability and symptoms of depression will be observed.
- Conditions
- Aging, Functional Status
- Being tested
- Physical training, Cognitive training
- Keywords
- Exercise, Cognitive training, Aging, Frailty, Occupational performance
- Medical subject headings
- Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
Older adults assigned to this group will undergo two weekly sessions of remote and supervised physical training at home for 1 hour on non-consecutive days. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures
Cognitive trainingBehavioural
These participants will also perform a weekly remote and supervised cognitive training session with neurobic exercises for 1 hour. In addition to the supervised cognitive training session, participants will also be prescribed asynchronous neurobic exercises to be performed on the remaining days of the week (without supervision). The intervention will last for 12 weeks, and all asynchronous neurobic exercises will be recorded in the following synchronous sessions by the supervisor. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures
| Study group | Role | What they receive |
|---|---|---|
| Physical and cognitive exercise group | Experimental | Participants will be randomized to receive physical and cognitive training for a period of 12 weeks. Receives: Behavioral: Physical training; Behavioral: Cognitive training |
| Physical exercise only group | Active comparator | Participants will be randomized to receive only physical training for a period of 12 weeks. Receives: Behavioral: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) performance
The TUG test will be used to measure possible modifications in the dynamic balance of older adults during the performance of the task.
Measured: Baseline (weeks 0) to Post-training (week 13)
Dual-task performance
The TUG test will also be applied with a dual task, in which participants' functional capacity will be assessed while simultaneously performing a verbal task. Specifically, the participants will perform the same procedures explained in the TUG test session, while also pronouncing the maximal number of animal names as possible.
Measured: Baseline (weeks 0) to Post-training (week 13)
Mini-Mental State Examination (MMSE) score
The MMSE will be used to assess participants' cognitive function, which will be classified based on the education-adjusted cut-off scores.
Measured: Baseline (weeks 0) to Post-training (week 13)
Secondary outcomes (7)
Handgrip strength
The amount of force produced by a maximal isometric contraction of the extrinsic hand muscles of the dominant upper limb will be measured using a hand dynamometer.
Measured: Baseline (weeks 0) to Post-training (week 13)
30-s Sit-to-Stand test performance
Lower limb strength will be assessed using the 30-s Sit-to-Stand test, which involves counting the number of times the participant can stand up completely from the sitting position, with arms crossed over the chest.
Measured: Baseline (weeks 0) to Post-training (week 13)
World Health Organization Quality of Life-bref (WHOQOL-bref) score
The WHOQOL-bref questionnaire covers four domains of quality of life (physical health, psychological health, social relationships, and environment) and will be used to assess self-reported quality of life.
Measured: Baseline (weeks 0) to Post-training (week 13)
Beck's Depression Inventory (BDI) score
The BDI is a self-administered questionnaire covering cognitive, affective, behavioral, and somatic aspects of depression.
Measured: Baseline (weeks 0) to Post-training (week 13)
Canadian Occupational Performance Measure (COPM)
The COPM is a semi-structured interview that uses a typical day as a reference to identify issues in self-care, productivity, and leisure based on the self-reported performance capacity and satisfaction of the patient in occupations the participant need, wants, and/or is expected to do.
Measured: Baseline (weeks 0) to Post-training (week 13)
Digit Span Test (DST)
The DST will be used to evaluate participants' working memory.
Measured: Baseline (weeks 0) to Post-training (week 13)
Verbal fluency test
Participants' verbal fluency will me assessed by asking participants to name as many different animals as they know in one minute.
Measured: Baseline (weeks 0) to Post-training (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start26 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Parallel groups
- Model description
- This is a randomized, single-blind, parallel, controlled, superiority trial. Older participants will be allocated into two groups, experimental and control, based on a randomization sequence that will be generated on a computer in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristine Lima Alberton, Federal University of Pelotas
- Investigators
- Cristine L Alberton, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309278
- Sponsor's protocol ID
- 55791522.6.0000.5313
- Status last verified
- Aug 2022
- First submitted
- 25 Mar 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berni FC, Kanitz AC, Miranda C, de Oliveira DB, Bergamin M, Bullo V, Schaun GZ, Alberton CL. Effects of a remotely supervised physical training program combined with cognitive training for older individuals at increased risk of clinical-functional vulnerability: study protocol for a randomized clinical trial. Trials. 2023 Aug 21;24(1):547. doi: 10.1186/s13063-023-07567-8.
PubMed 37599360
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Remote Physical Training Program Combined With Cognitive Training in Older Adults at Increased Risk of Clinical-functional Vulnerability: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05309278
- Acronym / sponsor ID
- 55791522.6.0000.5313
- Conditions
- Aging, Functional Status
- Keywords
- Exercise, Cognitive training, Aging, Frailty, Occupational performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Apr 2022 (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.
This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the self-reported quality of life.
Detailed description
Participants over 60 years of age at increased risk of clinical-functional vulnerability will be recruited in the city of Pelotas/RS, Brazil and randomized to two different arms. The intervention group will receive low-intensity physical training combined with a cognitive training program using neurobic exercises, whereas the active comparator group will only receive the low-intensity physical training program. Participants from both groups will perform their training sessions remotely for a total of 12 weeks. Outcomes of interest include handgrip strength, functional and cognitive capacity, occupational performance, clinical-functional vulnerability level, self-reported quality of life, and depressive symptoms, which will be assessed in a pre-post fashion. The study hypothesis is that remote low-intensity physical training combined with cognitive training will result in additional benefits to those of low-intensity physical training alone in the physical and cognitive capacity outcomes, and as a consequence, improved quality of life, occupational performance, decreased level of clinical-functional vulnerability and symptoms of depression will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, single-blind, parallel, controlled, superiority trial. Older participants will be allocated into two groups, experimental and control, based on a randomization sequence that will be generated on a computer in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Physical and cognitive exercise group | Experimental | Behavioral: Physical training, Behavioral: Cognitive trainingParticipants will be randomized to receive physical and cognitive training for a period of 12 weeks. |
| Physical exercise only group | Active comparator | Behavioral: Physical trainingParticipants will be randomized to receive only physical training for a period of 12 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 years of age or older,
- MMSE score equal to or greater than 19 points,
- Elementary school education complete or over,
- Sedentary (no current or previous participation in structured exercise (>1x/week) in the past 6 months),
- Increased risk of clinical-functional vulnerability, as determined by the Clinical-Functional Vulnerability Index-20 (IVCF-20) questionnaire.
Key exclusion criteria (5 listed)
- Individuals who have been affected by COVID-19,
- Not retired, or those retired individuals who maintained continuous or sporadic work activities,
- Neuromuscular deficits or any medical diagnosis that prevents the individuals from performing physical exercises,
- Individuals with decompensated or untreated blood pressure (> than 140x90 mmHg) and,
- Individuals with visual problems that prevent them from watching the training sessions on their cell phone or notebook screen.
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 |
|---|---|---|
| Physical trainingOlder adults assigned to this group will undergo two weekly sessions of remote and supervised physical training at home for 1 hour on non-consecutive days. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures | Behavioural | Physical and cognitive exercise group, Physical exercise only group |
| Cognitive trainingThese participants will also perform a weekly remote and supervised cognitive training session with neurobic exercises for 1 hour. In addition to the supervised cognitive training session, participants will also be prescribed asynchronous neurobic exercises to be performed on the remaining days of the week (without supervision). The intervention will last for 12 weeks, and all asynchronous neurobic exercises will be recorded in the following synchronous sessions by the supervisor. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures | Behavioural | Physical and cognitive exercise group |
Primary outcome
Timed Up and Go (TUG) performance
Time frame: Baseline (weeks 0) to Post-training (week 13)
The TUG test will be used to measure possible modifications in the dynamic balance of older adults during the performance of the task.
Dual-task performance
Time frame: Baseline (weeks 0) to Post-training (week 13)
The TUG test will also be applied with a dual task, in which participants' functional capacity will be assessed while simultaneously performing a verbal task. Specifically, the participants will perform the same procedures explained in the TUG test session, while also pronouncing the maximal number of animal names as possible.
Mini-Mental State Examination (MMSE) score
Time frame: Baseline (weeks 0) to Post-training (week 13)
The MMSE will be used to assess participants' cognitive function, which will be classified based on the education-adjusted cut-off scores.
7 secondary outcomes
Handgrip strength
Time frame: Baseline (weeks 0) to Post-training (week 13)
30-s Sit-to-Stand test performance
Time frame: Baseline (weeks 0) to Post-training (week 13)
World Health Organization Quality of Life-bref (WHOQOL-bref) score
Time frame: Baseline (weeks 0) to Post-training (week 13)
Beck's Depression Inventory (BDI) score
Time frame: Baseline (weeks 0) to Post-training (week 13)
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline (weeks 0) to Post-training (week 13)
Digit Span Test (DST)
Time frame: Baseline (weeks 0) to Post-training (week 13)
Verbal fluency test
Time frame: Baseline (weeks 0) to Post-training (week 13)
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 8 Aug 2025.
- Derived from this study: PubMed 37599360Berni FC, Kanitz AC, Miranda C, de Oliveira DB, Bergamin M, Bullo V, Schaun GZ, Alberton CL. Effects of a remotely supervised physical training program combined with cognitive training for older individuals at increased risk of clinical-functional vulnerability: study protocol for a randomized clinical trial. Trials. 2023 Aug 21;24(1):547. doi: 10.1186/s13063-023-07567-8.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Cristine L Alberton, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training and Cognitive training in people with Aging and Functional Status, run by Federal University of Pelotas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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 8 Aug 2025. 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 Brazil. 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?
Timed Up and Go (TUG) performance (time frame: Baseline (weeks 0) to Post-training (week 13)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309278, which also lists 1 linked publication.
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 8 Aug 2025.