NCT06048939

Brief Summary

This study proposes to find out the Combined Effect of Aerobic \& Resistance Training on physical, menstrual and psychological health of Adolescent Girls. The study results will be helpful to explore the mode and intensity of aerobic and resistance exercise and for creating strategies for improving the lifestyle of the adolescents by adopting the appropriate exercise guidelines.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

June 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

July 23, 2023

Last Update Submit

September 14, 2023

Conditions

Psychological Well-Being

Keywords

psychological well-beingMenstrual ProblemPhysical inactivity

Outcome Measures

Primary Outcomes (1)

  • Menstrual Health Instrument (MHI)

    The Menstrual Health Instrument (MHI) is a comprehensive 29-item scale that assesses the physical and emotional well-being of adolescents regarding menstruation. It covers five sub-scales and utilizes a 5-point Likert scale (from strongly disagree to strongly agree)

    at 1st week and after 12th week

Secondary Outcomes (1)

  • The Alpha Health Related Fitness Test Battery for Children And Adolescents

    at 1st week and after 12th week

Study Arms (2)

aerobic and resistance training

EXPERIMENTAL

moderate intensity aerobic and body weight resistance training on female adolescents.

Other: moderate intensity aerobic training and body weight resistance training

aerobic training

ACTIVE COMPARATOR

moderate intensity aerobic and body weight resistance training on female adolescents.

Other: moderate intensity aerobic training

Interventions

moderate intensity aerobic training and body weight resistance trainingOTHER

Bodyweight Resistance exercises Frequency: twice a week Intensity: moderate Time: 40 Minutes Warm up: 10mins Rotations and Dynamic stretches Body weight resistance Exercises: 20mins Calf raises (1 x 10-15 Reps) Squats (1 x 10-15 Reps) Lunges (1 x 10-15 Reps on each side) Modified push-ups (1 x 10-15 Reps) Bridging (1 x 10-15 Reps) Plank hold (10 Seconds) Side planks (10 Seconds each side) Cool down: 10 mins Slow marching and static stretches for next 6 weeks progression will be made by adding one more set of same exercises Aerobic training: Frequency: 2 Days per week Intensity: 60% of maximum heart rate. Time: 45 Minutes Exercise Protocol Warm up: 10mins Rotations and Dynamic stretches Aerobic exercises will be same as given to control group

aerobic and resistance training
moderate intensity aerobic trainingOTHER

Aerobic Exercises Frequency: 2 Days per week Intensity: 60% of maximum heart rate. Time: 45 Minutes Warm up: 10mins Rotations and Dynamic stretches Aerobic exercises: 25 mins (1 minute of each exercise with 60 seconds rest and repeating the same sequence for 1 minute.) Exercises will be performed at slow pace Marching, Single step touch, Step touches front and back, Double step touch, "V" step, knee lift, leg curl , forward walk, reach outs, lunge side and back, "L" Step, jumping jacks Cool down: 10 mins Slow marching and static stretches for next 6weeks progression will be made by increasing speed of same exercises

aerobic training

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female adolescents who have achieved Menarche.
  • years of age
  • BMI criteria: 17.50 - 22.99 (BMI Asia)
  • Score less than 13 on IPAQ (Inactive)

You may not qualify if:

  • History of musculoskeletal trauma or injury
  • Any diagnosed psychological condition
  • Participated in Exercise program for past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vega school system Dinga

Dinga, Punjab Province, 50280, Pakistan

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingMenstruation DisturbancesSedentary Behavior

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • summra andleeb, MS(OMPT)

    riphah internation university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

September 21, 2023

Study Start

June 22, 2023

Primary Completion

January 1, 2024

Study Completion

January 20, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)