Sedentary BehaviorNCT06461130
Effects of Dual-task Aerobic Exercise
A study testing Study Group in people with Sedentary Behavior, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the acute effect of dual-task aerobic exercise on cognitive load and myocardial oxygen consumption in healthy sedentary individuals. In this study: 1. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Study Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2024to 30 Sep 2024
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study
- No comorbidities
- Absence of comorbid diseases of the orthopedic, neurological, cardiopulmonary system
- Participants who have not been involved in another clinical trial in the last 1 month
Who cannot join
- Participants who had hip, pelvis, knee, ankle surgery in the last year
- Sensory loss
- Participants with leg length inequality
- Participants with known balance disorders in the last three months due to vestibular disorders, pregnancy, concussion
- Presence of systemic disease (diabetes, blood pressure, etc.)
- Those using bronchodilator drugs
- Having a neurological disease
- Not being in good psychological condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Dual-task Aerobic Exercise on Cognitive Load and Myocardial Oxygen Consumption in Healthy Sedentary Individuals
The aim of this study was to examine the acute effect of dual-task aerobic exercise on cognitive load and myocardial oxygen consumption in healthy sedentary individuals. In this study: 1. Does dual-task exercise applied in addition to aerobic training have an acute effect on cognitive load in healthy sedentary individuals? 2. Does dual-task exercise applied in addition to aerobic training in healthy sedentary individuals have an acute effect on myocardial oxygen consumption, which reflects the indirect oxygen consumption of the heart? The questions were answered.
Read the detailed description
To find answers to the questions of the study, healthy sedentary participants were randomized into two groups by online randomization method. One of the groups was the group that received only double-leg aerobic exercise. The other group was the double-leg aerobic exercise group integrated with dual-task-oriented training. Before and after the interventions, the blood pressure and pulse rate of the participants were measured, their cognitive functions were evaluated with the MOCA Test, their reaction times were evaluated with the Nelson Reaction Test, and the acute effect of the trainings was examined.
- Conditions
- Sedentary Behavior
- Being tested
- Study Group, Control Group
- Keywords
- dual task, aerobic training, cardiovascular, cognition
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study GroupOther
Group of people doing dual tasks during double-leg cycling training.
Control GroupOther
The group that received only aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| Double leg dual duty aerobic exercise group | Experimental | During double-leg cycling training, people were made to do dual tasks. Dual-task: aerobic training on a bicycle ergometer + serial sevens In the dual-task condition, participants completed the exercise while simultaneously performing a series of sevens cognitive tasks. Specifically, participants were instructed to serially subtract sevens from a prescribed three-digit number (range 100-300) and read the calculations aloud while performing aerobic exercise. Receives: Other: Study Group |
| Double leg standard aerobic exercise group | Active comparator | In double leg cycling training, both legs; Exercise was performed on the bicycle ergometer, starting with a 5-minute warm-up (25% labor force) on the ergometer before the application, lasting a total of 20 minutes, and continuously training at 70% intensity. Finished with 5 minutes of cooling. Individuals were allowed to maintain a pedaling frequency of 50 rpm, set externally with a metronome. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive load assessment
Cognitive load change was assessed with the Montreal Cognitive Function Assessment Scale (MOCA).
Measured: Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Myocardial oxygen consumption assessment
Myocardial oxygen consumption was calculated using the Double Product formula of the data obtained from blood pressure and pulse measurement.
Measured: Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Secondary outcomes (1)
Reaction time evaluation
Reaction time was determined by measuring the distance the ruler caught after the ruler was released.
Measured: Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start7 Jul 2024
- Primary completion16 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Yalova, Istanbul Gedik University
- Responsible party
- Principal investigator, ebrar atak, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461130
- Sponsor's protocol ID
- DualTaskwithAerobicTraining
- Status last verified
- Dec 2024
- First submitted
- 7 Jun 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Dual-task Aerobic Exercise on Cognitive Load and Myocardial Oxygen Consumption in Healthy Sedentary Individuals
- ClinicalTrials.gov ID
- NCT06461130
- Acronym / sponsor ID
- DualTaskwithAerobicTraining
- Conditions
- Sedentary Behavior
- Keywords
- dual task, aerobic training, cardiovascular, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- University of Yalova, Istanbul Gedik University
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Jun 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.
The aim of this study was to examine the acute effect of dual-task aerobic exercise on cognitive load and myocardial oxygen consumption in healthy sedentary individuals. In this study: 1. Does dual-task exercise applied in addition to aerobic training have an acute effect on cognitive load in healthy sedentary individuals? 2. Does dual-task exercise applied in addition to aerobic training in healthy sedentary individuals have an acute effect on myocardial oxygen consumption, which reflects the indirect oxygen consumption of the heart? The questions were answered.
Detailed description
To find answers to the questions of the study, healthy sedentary participants were randomized into two groups by online randomization method. One of the groups was the group that received only double-leg aerobic exercise. The other group was the double-leg aerobic exercise group integrated with dual-task-oriented training. Before and after the interventions, the blood pressure and pulse rate of the participants were measured, their cognitive functions were evaluated with the MOCA Test, their reaction times were evaluated with the Nelson Reaction Test, and the acute effect of the trainings was examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double leg dual duty aerobic exercise group | Experimental | Other: Study GroupDuring double-leg cycling training, people were made to do dual tasks. Dual-task: aerobic training on a bicycle ergometer + serial sevens In the dual-task condition, participants completed the exercise while simultaneously performing a series of sevens cognitive tasks. Specifically, participants were instructed to serially subtract sevens from a prescribed three-digit number (range 100-300) and read the calculations aloud while performing aerobic exercise. |
| Double leg standard aerobic exercise group | Active comparator | Other: Control GroupIn double leg cycling training, both legs; Exercise was performed on the bicycle ergometer, starting with a 5-minute warm-up (25% labor force) on the ergometer before the application, lasting a total of 20 minutes, and continuously training at 70% intensity. Finished with 5 minutes of cooling. Individuals were allowed to maintain a pedaling frequency of 50 rpm, set externally with a metronome. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- No comorbidities
- Absence of comorbid diseases of the orthopedic, neurological, cardiopulmonary system
- Participants who have not been involved in another clinical trial in the last 1 month
Key exclusion criteria (8 listed)
- Participants who had hip, pelvis, knee, ankle surgery in the last year
- Sensory loss
- Participants with leg length inequality
- Participants with known balance disorders in the last three months due to vestibular disorders, pregnancy, concussion
- Presence of systemic disease (diabetes, blood pressure, etc.)
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 |
|---|---|---|
| Study GroupGroup of people doing dual tasks during double-leg cycling training. | Other | Double leg dual duty aerobic exercise group |
| Control GroupThe group that received only aerobic exercise. | Other | Double leg standard aerobic exercise group |
Primary outcome
Cognitive load assessment
Time frame: Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Cognitive load change was assessed with the Montreal Cognitive Function Assessment Scale (MOCA).
Myocardial oxygen consumption assessment
Time frame: Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Myocardial oxygen consumption was calculated using the Double Product formula of the data obtained from blood pressure and pulse measurement.
1 secondary outcome
Reaction time evaluation
Time frame: Time to acute change in measurements 1 hour before the application and 1 hour after the application.
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 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 Study Group in people with Sedentary Behavior, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 17 Dec 2024. 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 Turkey (Türkiye). 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?
Cognitive load assessment (time frame: Time to acute change in measurements 1 hour before the application and 1 hour after the application.). 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 17 Dec 2024.