- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06047743
Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents
September 22, 2023 updated by: Riphah International University
Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents: A Randomized Clinical Trial
This study aims to compare the effects of upper and lower-extremity isometrics on cognition in healthy adolescents.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The literature suggests a positive impact of isometrics on cognition.
Identifying how cognitive results would differ in upper vs. lower extremity isometric groups is the main objective of the study.
for cognitive assessment, different aspects of cognition will be measured by all computer-based tools (except for Trail making A and B).
Study Type
Interventional
Enrollment (Estimated)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ramsha Abrar, DPT
- Phone Number: 923045136699
- Email: abrarramsha5@gmail.com
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46010
- Recruiting
- Academy of Islamic and Modern Studies (AIMS)
-
Contact:
- Ramsha Abrar, DPT
- Phone Number: 923045136699
- Email: abrarramsha5@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- School-going adolescents
- Both male and female students with a minimum age of 12 and a maximum of 18yrs
- Students with good school attendance
- Subjects who are willing to commit to the time commitments required by the program
Exclusion Criteria:
- Students with Physical or mental disabilities
- Those who suffered a fracture before
- Students with any morbidity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alternating unilateral Isometric Handgrip Exercise Group
Participants (n=19) will be performing alternating unilateral Isometric Handgrip exercises using a dynamometer for 3-5 days a week for a total duration of 8 weeks.
The participant will be seated with their elbow resting on the armrest and wrists off the supporting surface.
A single session will consist of 4 sets of 30%MVC (calculated by dynamometer) of handgrip exercise with a maximum 2 minutes contraction time/ hold time followed by a rest period/ recovery period of 1 minute during each set.
|
Participants (n=19) will be performing alternating unilateral Isometric Handgrip exercises using a dynamometer for 3-5 days a week for a total duration of 8 weeks.
The participant will be seated with their elbow resting on the armrest and wrists off the supporting surface.
A single session will consist of 4 sets of 30%MVC (calculated by dynamometer) of handgrip exercise with a maximum 2 minutes contraction time/ hold time followed by a rest period/ recovery period of 1 minute during each set.
|
Experimental: Dominant knee extension Isometric Exercise Group
Participants enrolled in this group will be performing dominant leg isometric knee extension.
The knee will be 35° flexed from a fully extended position when performing isometric knee extension using a hand-held dynamometer retrained by a belt.
The intervention duration will be 8 weeks.
A single session will consist of performing 4 sets of 30% MVC (calculated using a dynamometer) of unilateral knee extension isometrics with a maximum 2 minutes contraction time/ hold time followed by a rest/ recovery period of 1 minute during each set.
|
Participants enrolled in this group will be performing dominant leg isometric knee extension.
The knee will be 35° flexed from a fully extended position when performing isometric knee extension using a hand-held dynamometer retrained by a belt.
The intervention duration will be 8 weeks.
A single session will consist of performing 4 sets of 30% MVC (calculated using a dynamometer) of unilateral knee extension isometrics with a maximum 2 minutes contraction time/ hold time followed by a rest/ recovery period of 1 minute during each set.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corsi Block Test
Time Frame: Baseline
|
The Corsi block test or "Corsi block-tapping test" is a Short-term working memory (STM) task conceptually like the digital span test.
Its creator is Philip Michael Corsi.
In this test experimenter shows nine blocks arranged in front of the participant, The blocks are tapped in a certain sequence and the participant must repeat the same sequence.
The test is repeated a few times with different lengths of blocks.
The conclusion is drawn by observing the block/ corsi span.
The block span is the longest sequence a participant can repeat.
A healthy person has a block span of 5- 7.
|
Baseline
|
Corsi Block Test
Time Frame: After 4 weeks
|
The Corsi block test or "Corsi block-tapping test" is a Short-term working memory (STM) task conceptually like the digital span test.
Its creator is Philip Michael Corsi.
In this test experimenter shows nine blocks arranged in front of the participant, The blocks are tapped in a certain sequence and the participant must repeat the same sequence.
The test is repeated a few times with different lengths of blocks.
The conclusion is drawn by observing the block/ corsi span.
The block span is the longest sequence a participant can repeat.
A healthy person has a block span of 5- 7.
|
After 4 weeks
|
Corsi Block Test
Time Frame: After 8 weeks
|
The Corsi block test or "Corsi block-tapping test" is a Short-term working memory (STM) task conceptually like the digital span test.
Its creator is Philip Michael Corsi.
In this test experimenter shows nine blocks arranged in front of the participant, The blocks are tapped in a certain sequence and the participant must repeat the same sequence.
The test is repeated a few times with different lengths of blocks.
The conclusion is drawn by observing the block/ corsi span.
The block span is the longest sequence a participant can repeat.
A healthy person has a block span of 5- 7.
|
After 8 weeks
|
Free and delayed recall test
Time Frame: Baseline
|
Free and delayed recall are measures of episodic memory.
A 15-item word list of highly frequent words will be used.
At the outset, a "ready" cue will appear in the centre of the computer screen.
On the computer screen, each word will be displayed individually for 3 seconds.
After the 15th word, the participant will be given a 60-second to write down the words in any order.
The Delayed Recall test will be used to evaluate long-term memory about 12 minutes later.
During the delayed memory task, participants will be allowed 60 to recall as many words from the list shown before.
|
Baseline
|
Free and delayed recall test
Time Frame: After 4 weeks
|
Free and delayed recall are measures of episodic memory.
A 15-item word list of highly frequent words will be used.
At the outset, a "ready" cue will appear in the centre of the computer screen.
On the computer screen, each word will be displayed individually for 3 seconds.
After the 15th word, the participant will be given a 60-second to write down the words in any order.
The Delayed Recall test will be used to evaluate long-term memory about 12 minutes later.
During the delayed memory task, participants will be allowed 60 to recall as many words from the list shown before.
|
After 4 weeks
|
Free and delayed recall test
Time Frame: After 8 weeks
|
Free and delayed recall are measures of episodic memory.
A 15-item word list of highly frequent words will be used.
At the outset, a "ready" cue will appear in the centre of the computer screen.
On the computer screen, each word will be displayed individually for 3 seconds.
After the 15th word, the participant will be given a 60-second to write down the words in any order.
The Delayed Recall test will be used to evaluate long-term memory about 12 minutes later.
During the delayed memory task, participants will be allowed 60 to recall as many words from the list shown before.
|
After 8 weeks
|
Go/ No Go task
Time Frame: Baseline
|
Go/ No Go task or stop signal task is a measure of executive functioning.
This tool tests participant's ability to not respond thus measuring response inhibition and impulsivity.
The participant is required to respond within 2 seconds when the screen says 'Go' and should resist responding when 'No' appears.
|
Baseline
|
Go/ No Go task
Time Frame: After 4 week
|
Go/ No Go task or stop signal task is a measure of executive functioning.
This tool tests participant's ability to not respond thus measuring response inhibition and impulsivity.
The participant is required to respond within 2 seconds when the screen says 'Go' and should resist responding when 'No' appears
|
After 4 week
|
Go/ No Go task
Time Frame: After 8 weeks
|
Go/ No Go task or stop signal task is a measure of executive functioning.
This tool tests participant's ability to not respond thus measuring response inhibition and impulsivity.
The participant is required to respond within 2 seconds when the screen says 'Go' and should resist responding when 'No' appears
|
After 8 weeks
|
Stroop test
Time Frame: Baseline
|
The Stroop colour-word test is considered one of the gold standards of attentional measures and is one of the most widely used instruments in clinical and experimental neuropsychological settings.
In the Stroop-A test, the reader must note the colour rather than the word as soon as the word is highlighted.
In the Stroop-B, the evaluator points to the columns of coloured words, and the subject reads what is written.
To draw results Stroop effect is calculated by subtracting the reaction time of compatible trials from incompatible trials.
|
Baseline
|
Stroop test
Time Frame: After 4 weeks
|
The Stroop colour-word test is considered one of the gold standards of attentional measures and is one of the most widely used instruments in clinical and experimental neuropsychological settings.
In the Stroop-A test, the reader must note the colour rather than the word as soon as the word is highlighted.
In the Stroop-B, the evaluator points to the columns of coloured words, and the subject reads what is written.
To draw results Stroop effect is calculated by subtracting the reaction time of compatible trials from incompatible trials.
|
After 4 weeks
|
Stroop test
Time Frame: After 8 weeks
|
The Stroop colour-word test is considered one of the gold standards of attentional measures and is one of the most widely used instruments in clinical and experimental neuropsychological settings.
In the Stroop-A test, the reader must note the colour rather than the word as soon as the word is highlighted.
In the Stroop-B, the evaluator points to the columns of coloured words, and the subject reads what is written.
To draw results Stroop effect is calculated by subtracting the reaction time of compatible trials from incompatible trials.
|
After 8 weeks
|
Trail making A
Time Frame: Baseline
|
The trail-making test is a cognitive tool used for the assessment of processing speed, attention, and cognitive flexibility.
The test requires the person to draw lines in ascending order from 1-25 in the case of trail-making A. Trail-making A and B have numbers, as well as letters, joined in an alternating sequence.
The total score is calculated by subtracting the time taken for part A from the time taken to attempt part B in seconds.
If the person cannot complete the test in 5 minutes the test is discontinued.
|
Baseline
|
Trail making B
Time Frame: Baseline
|
The trail-making test is a cognitive tool used for the assessment of processing speed, attention, and cognitive flexibility.
The test requires the person to draw lines in ascending order from 1-25 in the case of trail-making A. Trail-making A and B have numbers, as well as letters, joined in an alternating sequence.
The total score is calculated by subtracting the time taken for part A from the time taken to attempt part B in seconds.
If the person cannot complete the test in 5 minutes the test is discontinued.
|
Baseline
|
Trail making A
Time Frame: After 4 weeks
|
The trail-making test is a cognitive tool used for the assessment of processing speed, attention, and cognitive flexibility.
The test requires the person to draw lines in ascending order from 1-25 in the case of trail-making A. Trail-making A and B have numbers, as well as letters, joined in an alternating sequence.
The total score is calculated by subtracting the time taken for part A from the time taken to attempt part B in seconds.
If the person cannot complete the test in 5 minutes the test is discontinued.
|
After 4 weeks
|
Trail making B
Time Frame: After 4 weeks
|
The trail-making test is a cognitive tool used for the assessment of processing speed, attention, and cognitive flexibility.
The test requires the person to draw lines in ascending order from 1-25 in the case of trail-making A. Trail-making A and B have numbers, as well as letters, joined in an alternating sequence.
The total score is calculated by subtracting the time taken for part A from the time taken to attempt part B in seconds.
If the person cannot complete the test in 5 minutes the test is discontinued.
|
After 4 weeks
|
Trail making A
Time Frame: After 8 weeks
|
The trail-making test is a cognitive tool used for the assessment of processing speed, attention, and cognitive flexibility.
The test requires the person to draw lines in ascending order from 1-25 in the case of trail-making A. Trail-making A and B have numbers, as well as letters, joined in alternating sequences.
The total score is calculated by subtracting the time taken for part A from the time taken to attempt part B in seconds.
If the person cannot complete the test in 5 minutes the test is discontinued.
|
After 8 weeks
|
Trail making B
Time Frame: After 8 weeks
|
The trail-making test is a cognitive tool used for the assessment of processing speed, attention, and cognitive flexibility.
The test requires the person to draw lines in ascending order from 1-25 in the case of trail-making A. Trail-making A and B have numbers, as well as letters, joined in alternating sequences.
The total score is calculated by subtracting the time taken for part A from the time taken to attempt part B in seconds.
If the person cannot complete the test in 5 minutes the test is discontinued.
|
After 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Borg Category-Ratio scale (CR)-10 Scale
Time Frame: Baseline
|
The Borg Category-Ratio scale, also known as the Borg CR-10 scale, is a self-report tool for gauging perceived effort intensity.
It is similar to the Borg Rating of Perceived Exertion Scale, but ratings are from 0 to 10.
This general intensity scale has category-ratio qualities that are more suited to the subjective feelings of effort, including pain, discomfort, and localized tiredness.
Participants will be cued to give their ratings using the standardized questions: "How hard do you feel your hand /leg muscles are working?" and will be scored against a rating of 0 to 10.
|
Baseline
|
Borg Category-Ratio scale (CR)-10 Scale
Time Frame: After 4 weeks
|
The Borg Category-Ratio scale, also known as the Borg CR-10 scale, is a self-report tool for gauging perceived effort intensity.
It is similar to the Borg Rating of Perceived Exertion Scale, but ratings are from 0 to 10.
This general intensity scale has category-ratio qualities that are more suited to the subjective feelings of effort, including pain, discomfort, and localized tiredness.
Participants will be cued to give their ratings using the standardized questions: "How hard do you feel your hand /leg muscles are working?" and will be scored against a rating of 0 to 10.
|
After 4 weeks
|
Borg Category-Ratio scale (CR)-10 Scale
Time Frame: After 8 weeks
|
The Borg Category-Ratio scale, also known as the Borg CR-10 scale, is a self-report tool for gauging perceived effort intensity.
It is similar to the Borg Rating of Perceived Exertion Scale, but ratings are from 0 to 10.
This general intensity scale has category-ratio qualities that are more suited to the subjective feelings of effort, including pain, discomfort, and localized tiredness.
Participants will be cued to give their ratings using the standardized questions: "How hard do you feel your hand /leg muscles are working?" and will be scored against a rating of 0 to 10.
|
After 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Imran Amjad, PhD, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2023
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
January 30, 2024
Study Registration Dates
First Submitted
September 14, 2023
First Submitted That Met QC Criteria
September 20, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC-01640 Ramsha Abrar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adolescents
-
University of California, San FranciscoAlliance for Decision EducationCompletedHealthy AdolescentsUnited States
-
The Swedish School of Sport and Health SciencesThe Knowledge Foundation; IKEA; Skandia; Konsumentföreningen Stockholm; Generation... and other collaboratorsCompleted
-
aysun ardıçCompletedOverweight Adolescents | Healthy Lifestyle Behaviors | Obese AdolescentsTurkey
-
University of IcelandEnrolling by invitationHealthy Adolescents in School-based PopulationIceland
-
Elizabeth Glaser Pediatric AIDS FoundationUnited States Agency for International Development (USAID); Biomedical Research... and other collaboratorsTerminatedOrphans, Children, Adolescents | Vulnerable Children, Adolescents | Community-basedZimbabwe
-
University of KansasNational Institute of Nursing Research (NINR)Completed
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Instituto de Salud Carlos III; Institut Catala de SalutUnknownSmoking in AdolescentsSpain
-
University of ÉvoraAgency for Science, Technology and ResearchCompleted
-
National Institutes of Health Clinical Center (CC)CompletedAdolescentsUnited States
-
University of CoimbraActive, not recruitingAthletes | AdolescentsPortugal
Clinical Trials on Alternating unilateral Isometric Handgrip Exercise
-
University of PernambucoCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo... and other collaboratorsCompleted
-
University of PernambucoFundação de Amparo à Pesquisa do Estado de São PauloCompletedPeripheral Artery DiseaseBrazil
-
Instituto de Cardiologia do Rio Grande do SulRecruitingArterial HypertensionBrazil
-
University of Nove de JulhoHospital Israelita Albert EinsteinRecruitingPeripheral Arterial DiseaseBrazil
-
KU LeuvenResearch Foundation FlandersCompleted
-
University of Lausanne HospitalsCompletedCoronary Artery Disease | Type 1 Diabetes MellitusSwitzerland
-
University of NottinghamThe Royal College of Surgeons of England; The Dunhill Medical TrustUnknownHypertension | Perioperative HypertensionUnited Kingdom
-
University of Massachusetts, BostonNot yet recruiting
-
University Institute of MaiaUniversity of Connecticut; Aveiro University; Hospital Infante D. Pedro, Centro... and other collaboratorsCompletedHypertension | Pre-HypertensionUnited States, Portugal
-
Swansea UniversityRecruitingHypertensionUnited Kingdom