- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06650345
Aerobic Exercise Effects on Cognitive Function in Aging Individuals
Exploring the Impact of Supervised Treadmill Aerobic Exercise on Cognitive Function and Apoptotic-Related Biomarkers in Aging Individuals
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- home resident older
- healthy individuals
- the participants were aged between 65 and 95
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: the control group
non-exercised participants with daily life activities
|
|
|
Experimental: exercise group
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 month
|
|
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.
|
3 month
|
|
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)
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of cognitive abilities
Time Frame: 3 month
|
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.
|
3 month
|
|
Assessment of serum Bcl-2 as apoptotic-related protein
Time Frame: 3 month
|
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
|
3 month
|
|
Assessment of serum cytochrome c as apoptotic-related protein
Time Frame: 3 month
|
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
|
3 month
|
|
Assessment of serum p53 (pg/ml) as apoptotic-related protein
Time Frame: 3 month
|
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.
|
3 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RRC-2013-015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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