Cognitive FunctionNCT06650345
Aerobic Exercise Effects on Cognitive Function in Aging Individuals
A study testing supervised aerobic exercise in people with Cognitive Function and Exercise Training, run by King Saud University.
Trial summary
Positive effects are exerted by participating in moderate exercise training with physical activity which positively affects body health, including cognitive abilities, among older adults. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Exercise Training
- What is being tested?
- supervised aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2013to 30 Dec 2014
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- home resident older
- healthy individuals
- the participants were aged between 65 and 95
Who cannot join
- Participants with Any physical impairments or conditions such as endocrine, immune, or psychiatric disorders
- participants with eating disorders
- participants' use of any glucocorticoid medications, which might impact the assessment of apoptotic and cognitive functions.
About this study
Official title: Exploring the Impact of Supervised Treadmill Aerobic Exercise on Cognitive Function and Apoptotic-Related Biomarkers in Aging Individuals
Positive effects are exerted by participating in moderate exercise training with physical activity which positively affects body health, including cognitive abilities, among older adults. Thus, the investigators are trying to study the potential effects of the supervised aerobic training regimen for 12 weeks on cognitive function among older adults based on molecular changes in cellular apoptosis.
Read the detailed description
Physical activity exerts many positive effects on body health, including cognitive abilities, among older adults. Nevertheless, a paucity of knowledge exists regarding the potential anti-apoptotic benefits of moderate exercise and its potential influence on cognitive function. The objective of the present study was to explore the possible connection between the anti-apoptotic mechanisms associated with exercise and cognitive performance in a cohort of 60 older adults who participated in a 12-week supervised aerobic training regimen.
A total of 120 healthy home residents and older subjects with an age range of 65 to 95 years were enrolled to participate in this study. Only, 60 subjects who met the inclusion criteria were included in this study.
The participants were categorized into two groups, specifically the control group (consisting of 30 individuals) and the exercise group (also comprising 30 individuals), based on their participation in an exercise program. Assessments of cognitive function, leisure-time physical activity (LTPA), and apoptotic-related markers such as Bcl-2, p53, and Cytochrome c were conducted both before and after a 12-week aerobic exercise intervention.
- Conditions
- Cognitive Function, Exercise Training
- Being tested
- supervised aerobic exercise
- Keywords
- Cognitive abilities ,Apoptosis, LOTCA,exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised aerobic exerciseOther
In this training program, the participants exercised for 45-60 minutes through intervals on a treadmill, bike, or stair climber, three times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| the control group | No intervention | non-exercised participants with daily life activities |
| exercise group | Experimental | participants engaged in a 12-week exercise regimen structured thrice weekly.Each session's intensity was customized to match the individual's maximum and resting heart rates. The warm-up involved stretching and a 5 to 10-minute walk. In the core exercise phase, participants aimed to reach their predetermined training heart rate (THR max; between 60 to 70%) for 45-60 minutes through intervals on a treadmill, bike, or stair climber.The exercise protocol was designed to elicit physical exertion equivalent to 30-45% of their maximum oxygen consumption (VO2 max) Receives: Other: supervised aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of body weight as anthropometric measurements
the impact of exercise training program on body weight was identified pre and post exercise period. Weight measurements in kilograms from all participants were estimated by employing a standardized approach, utilizing a tape measure and a calibrated Salter Electronic Scale (Digital Pearson Scale; ADAM Equipment Inc., Columbia, MD, USA). The calculated weights were used to estimate BMI of each recpective participant.
Measured: 3 month
Assessment of body height as anthropometric measurements
the impact of exercise training program on body height was identified pre and post exercise period. A standardized approach, utilizing a tape measure and a calibrated Salter Electronic Scale (Digital Pearson Scale; ADAM Equipment Inc., Columbia, MD, USA) were used to estimate body height of each participants. The values of body height in meters were used in combination with body weight to perform BMI of its respective participant.
Measured: 3 month
Assessment of BMI as as anthropometric measurements
Assessment of body mass index ( BMI in kg/m^2)as anthropometric measurements In this test, BMI from body weight and height measurements for each participant were estimated before and after exercise training interventions by using a bioelectrical impedance analysis (BIA) based body composition analyzer (TBF 105, Tanita Corporation, Tokyo, Japan)
Measured: 3 month
Secondary outcomes (4)
Assessment of cognitive abilities
the cognitive capabilities of the elderly participants prior and post structured aerobic exercise program using the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) battery.The LOTCA comprises seven primary domains, each further subdivided into 26 subtests. Scoring for each subtest was carried out utilizing either a four- or five-point Likert scale. The overall LOTCA score was obtained by summing the scores from all subtests. Scores on the test range from a minimum of 27 to a maximum of 123, where a higher score signifies superior cognitive function.
Measured: 3 month
Assessment of serum Bcl-2 as apoptotic-related protein
in this outcome measure, ELISA kits specifically designed for Bcl-2 (Cat# QIA23, Oncogene Research Products, Germany). The levels of serum Bcl-2 (µg/ml) were identified in all participants of control and exercised groups, pre- and post exercie training for 12 weeks
Measured: 3 month
Assessment of serum cytochrome c as apoptotic-related protein
Serum cytochrome c (ng /ml) was estimated in the serum of all participant's by using cytochrome c (Zymed ELISA Kit, Cat. No. 99-0040). The results were measured by immunoassay analysis using ELISA reader
Measured: 3 month
Assessment of serum p53 (pg/ml) as apoptotic-related protein
The quantification of p53 (pg/ml) concentration in the serum of all participants before and after exercise training was determined utilizing a single-step enzyme-immunoassay ELISA kit (Catalog Number 11 828 789 001; Roche Diagnostics GmbH, Roche Applied Science, Germany) based on photometric methods.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start25 Dec 2013
- Primary completion30 Nov 2014
- Study completion30 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were categorized into two groups, specifically the control group (consisting of 30 individuals) and the exercise group (also comprising 30 individuals), based on their participation in an exercise program.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Gabr, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650345
- Sponsor's protocol ID
- RRC-2013-015
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Supervised Treadmill Aerobic Exercise on Cognitive Function and Apoptotic-Related Biomarkers in Aging Individuals
- ClinicalTrials.gov ID
- NCT06650345
- Acronym / sponsor ID
- RRC-2013-015
- Conditions
- Cognitive Function, Exercise Training
- Keywords
- Cognitive abilities ,Apoptosis, LOTCA,exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 25 Dec 2013 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 21 Oct 2024 (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.
Positive effects are exerted by participating in moderate exercise training with physical activity which positively affects body health, including cognitive abilities, among older adults. Thus, the investigators are trying to study the potential effects of the supervised aerobic training regimen for 12 weeks on cognitive function among older adults based on molecular changes in cellular apoptosis.
Detailed description
Physical activity exerts many positive effects on body health, including cognitive abilities, among older adults. Nevertheless, a paucity of knowledge exists regarding the potential anti-apoptotic benefits of moderate exercise and its potential influence on cognitive function. The objective of the present study was to explore the possible connection between the anti-apoptotic mechanisms associated with exercise and cognitive performance in a cohort of 60 older adults who participated in a 12-week supervised aerobic training regimen.
A total of 120 healthy home residents and older subjects with an age range of 65 to 95 years were enrolled to participate in this study. Only, 60 subjects who met the inclusion criteria were included in this study.
The participants were categorized into two groups, specifically the control group (consisting of 30 individuals) and the exercise group (also comprising 30 individuals), based on their participation in an exercise program. Assessments of cognitive function, leisure-time physical activity (LTPA), and apoptotic-related markers such as Bcl-2, p53, and Cytochrome c were conducted both before and after a 12-week aerobic exercise intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were categorized into two groups, specifically the control group (consisting of 30 individuals) and the exercise group (also comprising 30 individuals), based on their participation in an exercise program.
| Arm | Type | Receives |
|---|---|---|
| the control group | No intervention | –non-exercised participants with daily life activities |
| exercise group | Experimental | Other: supervised aerobic exerciseparticipants engaged in a 12-week exercise regimen structured thrice weekly.Each session's intensity was customized to match the individual's maximum and resting heart rates. The warm-up involved stretching and a 5 to 10-minute walk. In the core exercise phase, participants aimed to reach their predetermined training heart rate (THR max; between 60 to 70%) for 45-60 minutes through intervals on a treadmill, bike, or stair climber.The exercise protocol was designed to elicit physical exertion equivalent to 30-45% of their maximum oxygen consumption (VO2 max) |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- home resident older
- healthy individuals
- the participants were aged between 65 and 95
Key exclusion criteria (3 listed)
- Participants with Any physical impairments or conditions such as endocrine, immune, or psychiatric disorders
- participants with eating disorders
- participants' use of any glucocorticoid medications, which might impact the assessment of apoptotic and cognitive functions.
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 |
|---|---|---|
| supervised aerobic exerciseIn this training program, the participants exercised for 45-60 minutes through intervals on a treadmill, bike, or stair climber, three times a week for 12 weeks. | Other | exercise group |
Primary outcome
Assessment of body weight as anthropometric measurements
Time frame: 3 month
the impact of exercise training program on body weight was identified pre and post exercise period. Weight measurements in kilograms from all participants were estimated by employing a standardized approach, utilizing a tape measure and a calibrated Salter Electronic Scale (Digital Pearson Scale; ADAM Equipment Inc., Columbia, MD, USA). The calculated weights were used to estimate BMI of each recpective participant.
Assessment of body height as anthropometric measurements
Time frame: 3 month
the impact of exercise training program on body height was identified pre and post exercise period. A standardized approach, utilizing a tape measure and a calibrated Salter Electronic Scale (Digital Pearson Scale; ADAM Equipment Inc., Columbia, MD, USA) were used to estimate body height of each participants. The values of body height in meters were used in combination with body weight to perform BMI of its respective participant.
Assessment of BMI as as anthropometric measurements
Time frame: 3 month
Assessment of body mass index ( BMI in kg/m^2)as anthropometric measurements In this test, BMI from body weight and height measurements for each participant were estimated before and after exercise training interventions by using a bioelectrical impedance analysis (BIA) based body composition analyzer (TBF 105, Tanita Corporation, Tokyo, Japan)
4 secondary outcomes
Assessment of cognitive abilities
Time frame: 3 month
Assessment of serum Bcl-2 as apoptotic-related protein
Time frame: 3 month
Assessment of serum cytochrome c as apoptotic-related protein
Time frame: 3 month
Assessment of serum p53 (pg/ml) as apoptotic-related protein
Time frame: 3 month
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 21 Oct 2024.
Related trials for Cognitive Function
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
RecruitingObservational study
Health, Imaging, and Cognition Across the Menopausal Transition
Menopause
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
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.
Questions about this trial
What is this clinical trial studying?
A study testing supervised aerobic exercise in people with Cognitive Function and Exercise Training, run by King Saud University.
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 3 inclusion and 3 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of body weight as anthropometric measurements (time frame: 3 month). 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?
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 21 Oct 2024.