NCT06086808

Brief Summary

The goal of this study is to determine the effect of resistance training on physical fitness, cognitive ability, and academic performance in young adults. This would be a randomized controlled trail in which participants will be randomly allocated in to two groups. One group will perform resistance training and other group will perform balance and general body toning exercises.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 4, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

Academic PerformanceCognitive FunctionExercise TrainingPhysical FitnessResistance Training

Outcome Measures

Primary Outcomes (8)

  • Isometric Strength (lbs)

    Isometric Strength will be assessed using a Hand-held Dynamometer measuring isometric contraction force in pounds (lbs).

    Baseline and after end of the intervention (3 months)

  • Endurance

    Endurance will be assessed using the Yo Yo Intermittent Recovery Level 1 Test ranging from speed level 5 (lightest) to speed level 23 (hardest).

    Baseline and after end of the intervention (3 months)

  • Agility

    Agility will be assessed using Illinois Agility Run Test (Time to complete it in seconds).

    Baseline and after end of the intervention (3 months)

  • Balance

    Balance will be assessed using Star Excursion Balance Test (distance in each direction).

    Baseline and after end of the intervention (3 months)

  • Stroop Test

    Stroop test will be used to assess cognitive function (number of items completed during each task).

    Baseline and after end of the intervention (3 months)

  • Trail Making Test

    Trail Making Test will be used to assess cognitive function (time spent to complete the task).

    Baseline and after end of the intervention (3 months)

  • Verbal Digit Span Test

    Verbal Digit Span Test will be used to assess cognitive function (number of digits recalled correctly).

    Baseline and after end of the intervention (3 months)

  • Academic Performance

    Academic performance will be assessed using previous and subsequent school grades of the participants.

    Baseline and after end of the intervention (3 months)

Study Arms (2)

Group A

EXPERIMENTAL

Resistance Training Group

Other: Resistance Training

Group B

ACTIVE COMPARATOR

General Fitness and Toning Group

Other: General Fitness and Toning

Interventions

A resistance training program will be used as a progressive, high-intensity protocol. The training stimulus will be provided using free weights. The exercises will consist of bench presses, biceps curls, triceps extensions, Latissimus Dorsi pull-down exercises, hamstring curls, and calf raises. The intensity of the training stimulus will be at a working range of 6 to 8 repetitions (2 sets). The training stimulus will subsequently be increased using the 7-RM (repetition maximum) method when 2 sets of 6 to 8 repetitions are completed with proper form and without discomfort. Other key strength exercises will include mini-squats, mini-lunges, and lunge walks. The number of sets completed and the load lifted for each exercise will be recorded for each participant in every class.

Group A

The general fitness and toning program will consist of stretching exercises, range-of-motion exercises, basic core-strengthening exercises, balance exercises, and relaxation techniques. Key balance exercises will include tandem stand, tandem walking, and single leg stance (eyes opened and closed). No additional loading (e.g., hand weights or resistance bands) will be applied to any of the exercises. This group will serve to control for confounding variables such as physical training received by traveling to the training centers, social interaction, and changes in life style secondary to study participation.

Group B

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • School going children between the ages of 12 to 17 year

You may not qualify if:

  • Participants with any recent musculoskeletal injury that hasn't healed.
  • Any deformity or disability that could affect the participant's ability to perform physical activity.
  • Any systemic disease/disorder that could affect the physical and cognitive performance of the participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University (RIU)

Islamabad, Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Noman Sadiq, MS-SPT

    Riphah International University, Islamabad.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noman Sadiq, MS-SPT

CONTACT

Tahreem Nisar, MS-SPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Concurrent Parallel Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 17, 2023

Study Start

August 15, 2023

Primary Completion

November 30, 2023

Study Completion

January 31, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations