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

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

Study Locations

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

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.

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

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.

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