NCT06941701

Brief Summary

This study aims to determine how different levels of physical fatigue influence cognitive load and performance during dual-task activities.

  1. 1.To assess the changes in cognitive task performance under varying levels of physical fatigue.
  2. 2.There is an association between cognitive loading and physical fatigue.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 7, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

Dual-Task Performance

Outcome Measures

Primary Outcomes (20)

  • Heart rate variability

    An electrocardiogram (ECG) will be utilized to assess heart rate variability, which will measure the fluctuations in time between heartbeats. Low heart rate variability will indicate increased cognitive load.

    Baseline

  • Heart rate variability (2nd reading)

    An electrocardiogram (ECG) will be utilized to assess heart rate variability, which will measure the fluctuations in time between heartbeats. Low heart rate variability will indicate increased cognitive load. 2nd reading will be measured during the cognitive task (without physical fatigue).

    Periprocedural

  • Heart rate variability (3rd reading)

    An electrocardiogram (ECG) will be utilized to assess heart rate variability, which will measure the fluctuations in time between heartbeats. Low heart rate variability will indicate increased cognitive load. 3rd reading will be measured after the cognitive task (without physical fatigue).

    Periprocedural

  • Heart rate variability (4rth reading)

    An electrocardiogram (ECG) will be utilized to assess heart rate variability, which will measure the fluctuations in time between heartbeats. Low heart rate variability will indicate increased cognitive load. 4rth reading will be measured after physical fatigue.

    Periprocedural

  • Heart rate variability (5th reading)

    An electrocardiogram (ECG) will be utilized to assess heart rate variability, which will measure the fluctuations in time between heartbeats. Low heart rate variability will indicate increased cognitive load. The 5th reading will be measured during the cognitive task after physical fatigue.

    Periprocedural

  • Heart rate variability (6th reading)

    An electrocardiogram (ECG) will be utilized to assess heart rate variability, which will measure the fluctuations in time between heartbeats. Low heart rate variability will indicate increased cognitive load. The 6th reading will be measured after the cognitive task, after physical fatigue.

    Periprocedural

  • Galvanic skin response

    The electrical conductance of the skin, measured by Galvanic Skin Response (GSR), will be influenced by moisture levels resulting from sweat gland activity. A high GSR will typically indicate an increased cognitive load.

    Baseline

  • Galvanic skin response (2nd reading)

    The electrical conductance of the skin, measured by Galvanic Skin Response (GSR), will be influenced by moisture levels resulting from sweat gland activity. A high GSR will typically indicate an increased cognitive load. 2nd reading will be measured during the cognitive task (without physical fatigue).

    Periprocedural

  • Galvanic skin response (3rd reading)

    The electrical conductance of the skin, measured by Galvanic Skin Response (GSR), will be influenced by moisture levels resulting from sweat gland activity. A high GSR will typically indicate an increased cognitive load. 3rd reading will be measured after the cognitive task (without physical fatigue).

    Periprocedural

  • Galvanic skin response (4rth reading)

    The electrical conductance of the skin, measured by Galvanic Skin Response (GSR), will be influenced by moisture levels resulting from sweat gland activity. A high GSR will typically indicate an increased cognitive load.4rth reading will be measured after physical fatigue.

    Periprocedural

  • Galvanic skin response (5th reading)

    The electrical conductance of the skin, measured by Galvanic Skin Response (GSR), will be influenced by moisture levels resulting from sweat gland activity. A high GSR will typically indicate an increased cognitive load. The 5th reading will be measured during the cognitive task after physical fatigue.

    Periprocedural

  • Galvanic skin response (6th reading)

    The electrical conductance of the skin, measured by Galvanic Skin Response (GSR), will be influenced by moisture levels resulting from sweat gland activity. A high GSR will typically indicate an increased cognitive load. The 6th reading will be measured after the cognitive task, after physical fatigue.

    Periprocedural

  • Nasa task load index

    The different dimensions of task load, including mental demand, physical demand, temporal demand, performance, effort, and frustration, will be measured subjectively using the NASA Task Load Index (TLX). Low ratings will typically indicate an increased cognitive load. 1st reading will be taken after the cognitive task, before inducing physical fatigue.

    Periprocedural

  • Nasa task load index (2nd reading)

    The different dimensions of task load, including mental demand, physical demand, temporal demand, performance, effort, and frustration, will be measured subjectively using the NASA Task Load Index (TLX). Low ratings will typically indicate an increased cognitive load. 2nd reading will be taken after the cognitive task, post physical fatigue induction.

    Periprocedural

  • Borg scale of perceived exertion

    After achieving the mild intensity target heart rate range of 50-60% through treadmill training, the Borg Rate of Perceived Exertion (RPE) category scale (6-20) will be utilized to assess exertion levels. A higher score on this scale will indicate greater physical exertion.

    Periprocedural

  • Borg scale of perceived exertion (Ist reading)

    Following the induction of physical fatigue, the Borg Rate of Perceived Exertion (RPE) category scale (6-20) will be used to evaluate exertion levels achieved during the treadmill training at the mild intensity target heart rate range of 50-60%. A higher score will reflect increased physical exertion. Ist reading will be taken after inducing physical fatigue.

    Periprocedural

  • Borg scale of perceived exertion (2nd reading)

    After achieving the moderate intensity target heart rate range of 60-70% through treadmill training, the Borg Rate of Perceived Exertion (RPE) category scale (6-20) will be utilized to assess exertion levels. A higher score on this scale will indicate greater physical exertion. 2nd reading will be taken after the cognitive task prior to inducing physical fatigue.

    Periprocedural

  • Borg scale of perceived exertion (3rd reading)

    Following the induction of physical fatigue, the Borg Rate of Perceived Exertion (RPE) category scale (6-20) will be used to evaluate exertion levels achieved during the treadmill training at the moderate intensity target heart rate range of 60-70%. A higher score will reflect increased physical exertion. 3rd reading will be taken after inducing physical fatigue.

    Periprocedural

  • Borg scale of perceived exertion (4rth reading)

    After achieving the High-intensity target heart rate range of 70-80% through treadmill training, the Borg Rate of Perceived Exertion (RPE) category scale (6-20) will be utilized to assess exertion levels. A higher score on this scale will indicate greater physical exertion. 4rth reading will be taken after the cognitive task, before inducing physical fatigue.

    Periprocedural

  • Borg scale of perceived exertion (5th reading)

    Following the induction of physical fatigue, the Borg Rate of Perceived Exertion (RPE) category scale (6-20) will be used to evaluate exertion levels achieved during the treadmill training at the High-intensity target heart rate range of 70-80%. A higher score will reflect increased physical exertion. 5th reading will be taken after inducing physical fatigue.

    Periprocedural

Study Arms (3)

Group 1

EXPERIMENTAL

Participants with a target Heart rate range of 50-60% of their maximum heart rate. All members of Group 1 who meet the eligibility criteria will perform a cognitive task before undergoing mild-intensity physical fatigue induced by treadmill training. After that participants will complete the cognitive task again. To eliminate bias, three different levels of physical exertion will be randomly assigned.

Other: Mild-intensity physical fatigue

Group 2

EXPERIMENTAL

Participants with a target Heart rate range of 60-70% of their maximum heart rate. All members of group 2 who meet the eligibility criteria will perform a cognitive task before undergoing moderate-intensity physical fatigue induced by treadmill training. After that participants will complete the cognitive task again. To eliminate bias, three different levels of physical exertion will be randomly assigned.

Other: Moderate-intensity physical fatigue

Group 3

EXPERIMENTAL

Participants with a target Heart rate range of 70-80% of their maximum heart rate. All members of group 3 who meet the eligibility criteria will perform a cognitive task before undergoing high-intensity physical fatigue induced by treadmill training. After that participants will complete the cognitive task again. To eliminate bias, three different levels of physical exertion will be randomly assigned.

Other: High-intensity physical fatigue

Interventions

Participants will undergo mild-intensity physical fatigue through a structured treadmill training protocol. The training will be conducted within a target heart rate range of 50-60% of their maximum heart rate (HRmax), ensuring controlled and consistent exercise intensity. This approach aims to induce mild physiological stress while maintaining safety and feasibility for all participants.

Group 1

Participants will undergo Moderate-intensity physical fatigue through a structured treadmill training protocol. The training will be conducted within a target heart rate range of 60-70% of their maximum heart rate (HRmax), ensuring controlled and consistent exercise intensity. This approach aims to induce mild physiological stress while maintaining safety and feasibility for all participants.

Group 2

Participants will undergo High-intensity physical fatigue through a structured treadmill training protocol. The training will be conducted within a target heart rate range of 70-80% of their maximum heart rate (HRmax), ensuring controlled and consistent exercise intensity. This approach aims to induce sufficient physiological stress while maintaining safety and feasibility for all participants.

Group 3

Eligibility Criteria

Age18 Years - 30 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll male and female healthy students are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged 18 to 30 years.
  • Physically healthy individuals.
  • Willingness to participate in the study.

You may not qualify if:

  • Cognitive Impairment.
  • Neurological injury.
  • Cardiac, pulmonary, or inflammatory diseases.
  • Mental health conditions include depression and post-traumatic stress disorder.
  • Individuals unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Imran Amjad, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Reserach
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 24, 2025

Study Start

April 23, 2025

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations