NCT06047743

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

September 14, 2023

Last Update Submit

May 19, 2024

Conditions

Keywords

CognitionIsometrics

Outcome Measures

Primary Outcomes (18)

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

  • 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.

    Baseline

  • 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

    After 4 week

  • 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

    After 8 weeks

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

  • 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.

    Baseline

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

  • 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.

    After 8 weeks

Secondary Outcomes (3)

  • Borg Category-Ratio scale (CR)-10 Scale

    Baseline

  • Borg Category-Ratio scale (CR)-10 Scale

    After 4 weeks

  • Borg Category-Ratio scale (CR)-10 Scale

    After 8 weeks

Study Arms (2)

Alternating unilateral Isometric Handgrip Exercise Group

EXPERIMENTAL

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

Dominant knee extension Isometric Exercise Group

EXPERIMENTAL

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

Interventions

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.

Alternating unilateral Isometric Handgrip 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.

Dominant knee extension Isometric Exercise Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academy of Islamic and Modern Studies (AIMS)

Rawalpindi, Punjab Province, 46010, Pakistan

Location

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

September 22, 2023

Primary Completion

December 31, 2023

Study Completion

January 30, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations