Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents

May 19, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46010
        • Academy of Islamic and Modern Studies (AIMS)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Alternating unilateral Isometric Handgrip Exercise
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.
Other: Dominant knee extension Isometric Exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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