Aerobic ExerciseNCT02648945
Effects of Low and High Intensity Exercise in Improving Working Memory Among Students With Anxiety Symptoms
A study testing Exercise in people with Aerobic Exercise, run by Manisha Parai at 1 site in Malaysia.
Trial summary
Anxiety levels among the younger generation especially students have been increasing drastically in recent years. This severely affects a student's academics as previous studies have shown a strong correlation between high anxiety levels and poor working memory. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2015to Feb 2016
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female students (Age group: 18-25 years)
- Participants with mild to severe anxiety levels (Score of >8)
Who cannot join
- Participants with Cardiorespiratory problems (e.g. Asthma, Congestive heart disorders) or severe Musculoskeletal problems that prevent them from carrying out any physical exercise or advised by personal physician not to.
- Participants that have had a recent head injury (recent 5 years)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Tunku Abdul Rahman
Kajang, Selangor, 43000
Manisha Parai, MPT, 0173128276
About this study
Official title: A Comparative Study Between Effects of Low and High Intensity Exercise in Improving Working Memory Among Students With Anxiety Symptoms
Anxiety levels among the younger generation especially students have been increasing drastically in recent years. This severely affects a student's academics as previous studies have shown a strong correlation between high anxiety levels and poor working memory. Working memory, also known as short term memory is an important component in studying as it aids in holding important information needed to understand following information for a short period of time. This concerning phenomenon has drawn the attention of researchers to find solutions to this issue where recent studies have found physical exercise to contribute in the improvement of cognition which also includes working memory. Hence, the aim of this study is to compare the effects of low and high intensity exercises on working memory among students with high anxiety levels. Thirty female undergraduate students from UTAR with relatively high levels of anxiety will be conveniently sampled using Beck Anxiety Inventory. Participants will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a treadmill according to Balke's Protocol. 2 memory assessments involving Verbal Memory Task will be conducted for each participant before and after the intervention.
- Conditions
- Aerobic Exercise
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
first, Verbal Memory task was completed by each participant. Participant then started walking on the treadmill at either a speed of 3.0 mph (4.8 km/h) for sedentary individuals or 3.5 mph (5.6 km/h) for active individuals with grade 0% (Hanson, 1984). This was followed by an increase in grade of 2% for every 2 mins with the speed remaining constant until targeted HR was reached. A heart rate (HR) monitor (POLAR®) was used to measure HR throughout the test and rating of perceived exertion (RPE) was done at the end of every 2 min stage. Exercise was stopped as soon as participant reaches targeted HR or requests to stop because of fatigue or any discomfort. Participant was then given time to cool down until HR reached or fell below 120 bpm and was allowed to take a break for approximately 1 min before proceeding with the second set of Verbal Memory Task. Upon completing the memory test, the participant was allowed to leave
| Study group | Role | What they receive |
|---|---|---|
| high intensity exercise | Active comparator | high intensity exercise on a treadmill according to Balke's Protocol.
high intensity of exercises for each group of 15 participants were set at 80-85% VO2 max (Schneider, S., et al., 2009). To determine the targeted HR for low and high intensity aerobic exercise for each participant, the needed VO2 max percentages were subbed into the Swain equation as follows: %VO2 max = (%HRmax - 37)/0.64 Exercise HR/HRmax = %HRmax
After rearrangement, it will be:
%HRmax = %VO2 max x 0.64 + 37 Exercise HR = %HRmax x HRmax During the experimental session, each participant performed physical exercise training on the treadmill according to Balke's Protocol. The reliability of this protocol was tested by Leddy, et. al. (2011). Receives: Other: Exercise |
| low intensity exercise | Active comparator | low intensity exercise on a treadmill according to Balke's Protocol. low intensity of exercises for each group of 15 participants were set at 50-55% VO2 max (Schneider, S., et al., 2009). To determine the targeted HR for low and high intensity aerobic exercise for each participant, the needed VO2 max percentages were subbed into the Swain equation as follows: %VO2 max = (%HRmax - 37)/0.64 Exercise HR/HRmax = %HRmax
After rearrangement, it will be:
%HRmax = %VO2 max x 0.64 + 37 Exercise HR = %HRmax x HRmax During the experimental session, each participant performed physical exercise training on the treadmill according to Balke's Protocol. The reliability of this protocol was tested by Leddy, et. al. (2011). Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Verbal Memory Task
Immediate effect of low and high intensity exercise
Measured: baseline and 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manisha Parai
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Tunku Abdul Rahman
- Responsible party
- Sponsor-investigator, Manisha Parai, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648945
- Sponsor's protocol ID
- U/SERC/86/2015
- Status last verified
- Feb 2016
- First submitted
- 4 Jan 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Effects of Low and High Intensity Exercise in Improving Working Memory Among Students With Anxiety Symptoms
- ClinicalTrials.gov ID
- NCT02648945
- Acronym / sponsor ID
- U/SERC/86/2015
- Conditions
- Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manisha ParaiUniversity, hospital or other
- Collaborators
- Universiti Tunku Abdul Rahman
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
Anxiety levels among the younger generation especially students have been increasing drastically in recent years. This severely affects a student's academics as previous studies have shown a strong correlation between high anxiety levels and poor working memory. Working memory, also known as short term memory is an important component in studying as it aids in holding important information needed to understand following information for a short period of time. This concerning phenomenon has drawn the attention of researchers to find solutions to this issue where recent studies have found physical exercise to contribute in the improvement of cognition which also includes working memory. Hence, the aim of this study is to compare the effects of low and high intensity exercises on working memory among students with high anxiety levels. Thirty female undergraduate students from UTAR with relatively high levels of anxiety will be conveniently sampled using Beck Anxiety Inventory. Participants will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a treadmill according to Balke's Protocol. 2 memory assessments involving Verbal Memory Task will be conducted for each participant before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high intensity exercise | Active comparator | Other: Exercisehigh intensity exercise on a treadmill according to Balke's Protocol. high intensity of exercises for each group of 15 participants were set at 80-85% VO2 max (Schneider, S., et al., 2009). To determine the targeted HR for low and high intensity aerobic exercise for each participant, the needed VO2 max percentages were subbed into the Swain equation as follows: %VO2 max = (%HRmax - 37)/0.64 Exercise HR/HRmax = %HRmax After rearrangement, it will be: %HRmax = %VO2 max x 0.64 + 37 Exercise HR = %HRmax x HRmax During the experimental session, each participant performed physical exercise training on the treadmill according to Balke's Protocol. The reliability of this protocol was tested by Leddy, et. al. (2011). |
| low intensity exercise | Active comparator | Other: Exerciselow intensity exercise on a treadmill according to Balke's Protocol. low intensity of exercises for each group of 15 participants were set at 50-55% VO2 max (Schneider, S., et al., 2009). To determine the targeted HR for low and high intensity aerobic exercise for each participant, the needed VO2 max percentages were subbed into the Swain equation as follows: %VO2 max = (%HRmax - 37)/0.64 Exercise HR/HRmax = %HRmax After rearrangement, it will be: %HRmax = %VO2 max x 0.64 + 37 Exercise HR = %HRmax x HRmax During the experimental session, each participant performed physical exercise training on the treadmill according to Balke's Protocol. The reliability of this protocol was tested by Leddy, et. al. (2011). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female students (Age group: 18-25 years)
- Participants with mild to severe anxiety levels (Score of >8)
Key exclusion criteria (2 listed)
- Participants with Cardiorespiratory problems (e.g. Asthma, Congestive heart disorders) or severe Musculoskeletal problems that prevent them from carrying out any physical exercise or advised by personal physician not to.
- Participants that have had a recent head injury (recent 5 years)
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 |
|---|---|---|
| Exercisefirst, Verbal Memory task was completed by each participant. Participant then started walking on the treadmill at either a speed of 3.0 mph (4.8 km/h) for sedentary individuals or 3.5 mph (5.6 km/h) for active individuals with grade 0% (Hanson, 1984). This was followed by an increase in grade of 2% for every 2 mins with the speed remaining constant until targeted HR was reached. A heart rate (HR) monitor (POLAR®) was used to measure HR throughout the test and rating of perceived exertion (RPE) was done at the end of every 2 min stage. Exercise was stopped as soon as participant reaches targeted HR or requests to stop because of fatigue or any discomfort. Participant was then given time to cool down until HR reached or fell below 120 bpm and was allowed to take a break for approximately 1 min before proceeding with the second set of Verbal Memory Task. Upon completing the memory test, the participant was allowed to leave | Other | high intensity exercise, low intensity exercise |
Primary outcome
Change in Verbal Memory Task
Time frame: baseline and 1 minutes
Immediate effect of low and high intensity exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aerobic Exercise, run by Manisha Parai at 1 site in Malaysia.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2016. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Verbal Memory Task (time frame: baseline and 1 minutes). 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 9 Feb 2016.