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Healthy AdolescentsNCT06047743

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

A study testing Alternating unilateral Isometric Handgrip Exercise and Dominant knee extension Isometric Exercise in people with Healthy Adolescents, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to compare the effects of upper and lower-extremity isometrics on cognition in healthy adolescents. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adolescents
What is being tested?
Alternating unilateral Isometric Handgrip Exercise and Dominant knee extension Isometric Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
22 Sep 2023to 30 Jan 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 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Students with Physical or mental disabilities
  • Those who suffered a fracture before
  • Students with any morbidity

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Academy of Islamic and Modern Studies (AIMS)

    Rawalpindi, Punjab Province, 46010

Other trials in Pakistan

About this study

Official title: 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.

Read the 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).

Being tested
Alternating unilateral Isometric Handgrip Exercise, Dominant knee extension Isometric Exercise
Keywords
Cognition, Isometrics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alternating unilateral Isometric Handgrip ExerciseOther

    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.

  • Dominant knee extension Isometric ExerciseOther

    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.

Study groups in NCT06047743
Study groupRoleWhat they receive
Alternating unilateral Isometric Handgrip Exercise GroupExperimentalParticipants (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.
Receives: Other: Alternating unilateral Isometric Handgrip Exercise
Dominant knee extension Isometric Exercise GroupExperimentalParticipants 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.
Receives: Other: Dominant knee extension Isometric Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Corsi Block Test

    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.

    Measured: Baseline

  2. Corsi Block Test

    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.

    Measured: After 4 weeks

  3. Corsi Block Test

    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.

    Measured: After 8 weeks

  4. Free and delayed recall test

    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.

    Measured: Baseline

  5. Free and delayed recall test

    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.

    Measured: After 4 weeks

  6. Free and delayed recall test

    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.

    Measured: After 8 weeks

  7. Go/ No Go task

    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.

    Measured: Baseline

  8. Go/ No Go task

    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

    Measured: After 4 week

  9. Go/ No Go task

    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

    Measured: After 8 weeks

  10. Stroop test

    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.

    Measured: Baseline

  11. Stroop test

    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.

    Measured: After 4 weeks

  12. Stroop test

    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.

    Measured: After 8 weeks

  13. Trail making A

    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.

    Measured: Baseline

  14. Trail making B

    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.

    Measured: Baseline

  15. Trail making A

    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.

    Measured: After 4 weeks

  16. Trail making B

    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.

    Measured: After 4 weeks

  17. Trail making A

    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.

    Measured: After 8 weeks

  18. Trail making B

    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.

    Measured: After 8 weeks

Secondary outcomes (3)
  1. Borg Category-Ratio scale (CR)-10 Scale

    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.

    Measured: Baseline

  2. Borg Category-Ratio scale (CR)-10 Scale

    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.

    Measured: After 4 weeks

  3. Borg Category-Ratio scale (CR)-10 Scale

    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.

    Measured: After 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start22 Sep 2023
  3. Primary completion31 Dec 2023
  4. Study completion30 Jan 2024

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047743
Sponsor's protocol ID
REC-01640 Ramsha Abrar
Status last verified
May 2024
First submitted
14 Sep 2023
Last updated
21 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Alternating unilateral Isometric Handgrip Exercise and Dominant knee extension Isometric Exercise in people with Healthy Adolescents, run by Riphah International University at 1 site in Pakistan.

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 3 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 21 May 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 Pakistan. 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?

Corsi Block Test (time frame: Baseline). The study lists 18 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 21 May 2024.

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