NCT07542574

Brief Summary

This study examined the effects of a school-based football intervention, the "11 for Health" (11fH) programme, on cardiorespiratory health, musculoskeletal fitness, health knowledge and well-being among Pakistani school children. The main questions it aimed to answer were:

  • Does the programme enhance Pakistani schoolchildren's cardiorespiratory health and physical fitness, including blood pressure, resting heart rate, aerobic capacity, horizontal jumping ability, agility, 30-m sprint, postural balance, BMI and waist circumference?
  • Does it improve their health knowledge and well-being? Researchers compared students who participated in the "11 for Health" intervention to those who continued their regular school curriculum. 254 fifth- and sixth-grade students (126 boys, 128 girls) from five schools in Islamabad participated in this study, allocated to an 11-week intervention group, a 5-week intervention group, and a control group. Researchers tested all groups before and after the intervention. Cardiorespiratory health and physical fitness were assessed with standardized tests. Health knowledge and well-being were measured with validated Urdu questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

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

Study Start

First participant enrolled

May 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 12, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

11 for HealthPhysical FitnessCardiorespiratory HealthHealth KnowledgeWell-beingPhysical EducationPhysical Activity

Outcome Measures

Primary Outcomes (11)

  • Resting Heart Rate

    Resting heart rate (RHR) was measured four times using a portable liquid crystal display (LCD) finger-type pulse oximeter. Prior to RHR measurement, participants were required to rest in a seated position for 15-20 minutes. Four measurements were taken for each participant, with at least 2-minute intervals between readings. Unit of Measurement: Beats per minute (bpm)

    before and at the end of the 11-week intervention

  • Systolic Blood Pressure and Diastolic Blood Pressure

    Trained staff measured blood pressure using an aneroid sphygmomanometer. The first and fifth Korotkoff sounds were recorded as systolic (SBP) and diastolic (DBP) pressure. Participants rested seated for 15-20 minutes beforehand. Four readings were taken at intervals of at least two minutes. Unit of Measurement: Millimeters of Mercury (mmHg)

    before and at the end of the 11-week intervention

  • Body Mass Index (BMI)

    Weight and Height were combined to report BMI in kg/m\^2. Height was measured to the nearest 0.1 cm using a yardstick. Weight was recorded with a 0.1 kg precision using a portable calibrated scale. These measurements were conducted with participants barefoot and wearing light clothing. Unit of Measurement: BMI in kg/m\^2

    before and at the end of the 11-week intervention

  • Waist Circumference

    Waist circumference (WC) was assessed at the midpoint between the lowest rib and the superior border of the iliac crest at the end of normal expiration, using a non-stretch measuring tape held parallel to the floor. Unit of Measurement: centimetre (cm) for the waist circumference

    before and at the end of the 11-week intervention

  • Postural Balance

    Postural balance was assessed using the Stork balance stand test. Participants placed their hands on hips, positioned one foot against the supporting leg's knee, and raised the supporting heel to balance on the ball of the foot. Timing began at heel lift and stopped if hands moved, the foot shifted, knee contact broke, or the heel touched down. Unit of Measurement: seconds (s)

    before and at the end of the 11-week intervention

  • Jump Performance

    Jump performance was assessed by standing long jump test. Each student performed two barefoot jumps. Starting with toes behind a line, feet parallel and shoulder-width apart, they squatted to 90° knee flexion with hands on hips. After two seconds, they jumped forward, keeping hands on hips. Unit of Measurement: Distance from line to heel was measured to the nearest centimetre (cm).

    before and at the end of the 11-week intervention

  • Agility

    The Arrow-head agility test is used to measure agility. Participants sprint from a start line to a middle cone, turn right around a side cone, circle the farthest cone, and return. Knocking over a cone requires a restart. Two attempts were made after one trial. The shorter time of the two attempts was recorded. Unit of Measurement: Seconds (s) - Time to complete the test

    before and at the end of the 11-week intervention

  • 30-metre Sprint

    The participants performed two 30-metre sprints at their maximal speed with 2-3 minutes of rest between attempts. Three timers with stopwatches stood 6 metres perpendicular to the finish line. They started timing at the student's first movement and stopped when the upper body crossed the finish line. Unit of Measurement: The average time in seconds (s) given by testers.

    before and at the end of the 11-week intervention

  • Cardiovascular Performance

    Cardiovascular performance was evaluated with the Yo-Yo intermittent recovery level 1 children's test. The test took place outdoors at all schools. It consisted of repeated 16-metre shuttle runs with progressively increasing speed. Between runs, participants had a 10 second active recovery by jogging around a cone set 4 metres behind the start line. A prerecorded beep regulated the pace. Missing the beep twice terminated the test. Unit of Measurement: Total running distance in metres (m)

    before and at the end of the 11-week intervention

  • Health Knowledge

    A 34-item Urdu version health knowledge questionnaire assessed children's understanding of ten health topics related to the "11 for Health" programme before and after the intervention. Items used either a true/false/don't know format or multiple choice with four options. Correct answers received a score of 2, while incorrect or don't know responses scored 1. Unit of Measurement: Mean percentage and standard deviation of correct responses were calculated for each health message based on all individual answers.

    before and at the end of the 11-week intervention

  • Well-being

    An Urdu version of the adapted KIDSCREEN-27 questionnaire was used to measure well-being of the partcipants. The 20 items covered four dimensions: physical well-being, psychological well-being, peers and social support, and school environment. Items used a five-point Likert scale ranging from "never" to "always" or "not at all" to "extremely". The subscale scores are converted to a standardized scale where the average is around 50 and the standard deviation is about 10. Higher scores reflected better well-being.

    before and at the end of the 11-week intervention

Study Arms (3)

11-week Intervention Group

EXPERIMENTAL

The 11-week Intervention Group participated in the complete "11 for Health" program for 11 weeks.

Other: "11 for Health" Intervention Programme

5-week Intervention Group

EXPERIMENTAL

The 5-week Intervention Group completed the last 5-week intervention program after returning school (the new semester began).

Other: "11 for Health" Intervention Programme

Control Group

NO INTERVENTION

The control group continued with their regular daily life and school activities.

Interventions

The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, including a "Play Football" session that focused on developing specific football skills, and a "Play Fair" session that delivered health education through football-related activities, replacing traditional chalkboard instruction. Small-sided games (3v3, 4v4) were included in every session as the main physical stimulus.

11-week Intervention Group5-week Intervention Group

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrollment in Grade 5 or Grade 6 in the participating schools during the 2023 to 2024 academic year
  • Provision of written informed consent from parents or guardians together with assent from the students

You may not qualify if:

  • Inability to provide consent or assent and medical conditions that prevented participation in football or other moderate-to-vigorous physical activities. Examples included severe mobility limitations, serious cardiovascular disease, or severe asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khursheed Hockey Ground, F-10/1, Islamabad

Islamabad, Pakistan

Location

Related Publications (6)

  • Moller TK, Larsen MN, Pfeffer K, Frydenlund SE, Ntoumanis N, Krustrup P. The effects of a combined physical activity and health education program on health knowledge and well-being of socially vulnerable children. Scand J Med Sci Sports. 2024 Apr;34(4):e14606. doi: 10.1111/sms.14606.

    PMID: 38545956BACKGROUND
  • Madsen M, Elbe AM, Madsen EE, Ermidis G, Ryom K, Wikman JM, Rasmussen Lind R, Larsen MN, Krustrup P. The "11 for Health in Denmark" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT. Scand J Med Sci Sports. 2020 Sep;30(9):1787-1795. doi: 10.1111/sms.13704. Epub 2020 May 27.

    PMID: 32353906BACKGROUND
  • Fuller CW, Orntoft C, Larsen MN, Elbe AM, Ottesen L, Junge A, Dvorak J, Krustrup P. 'FIFA 11 for Health' for Europe. 1: effect on health knowledge and well-being of 10- to 12-year-old Danish school children. Br J Sports Med. 2017 Oct;51(20):1483-1488. doi: 10.1136/bjsports-2016-096123. Epub 2016 Apr 29.

    PMID: 27130925BACKGROUND
  • Li Z, Krustrup P, Randers MB, Xu B, Yang W, Huang Z, Mao L. "11 for Health" in China - Effects on physical fitness in 9-11-year-old schoolchildren. Eur J Sport Sci. 2023 Dec;23(12):2291-2298. doi: 10.1080/17461391.2023.2227139. Epub 2023 Jul 1.

    PMID: 37338107BACKGROUND
  • Skoradal MB, Purkhus E, Steinholm H, Olsen MH, Orntoft C, Larsen MN, Dvorak J, Mohr M, Krustrup P. "FIFA 11 for Health" for Europe in the Faroe Islands: Effects on health markers and physical fitness in 10- to 12-year-old schoolchildren. Scand J Med Sci Sports. 2018 Aug;28 Suppl 1:8-17. doi: 10.1111/sms.13209. Epub 2018 Jun 8.

    PMID: 29882318BACKGROUND
  • Orntoft C, Fuller CW, Larsen MN, Bangsbo J, Dvorak J, Krustrup P. 'FIFA 11 for Health' for Europe. II: effect on health markers and physical fitness in Danish schoolchildren aged 10-12 years. Br J Sports Med. 2016 Nov;50(22):1394-1399. doi: 10.1136/bjsports-2016-096124. Epub 2016 Apr 29.

    PMID: 27130927BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D. Candidate

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 21, 2026

Study Start

May 13, 2024

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Measurements: Data obtained from physical fitness tests (YYIR1C, standing long jump, arrowhead agility test, 30-metre sprint, Stork balance test), cardiorespiratory health measurements (e.g. BP, RHR), health knowledge and well-being assessments will be shared. Data Anonymization: All shared data will be fully anonymized to ensure participant confidentiality. Personal identifiers such as names, birth dates, and schools will be removed. Data will be reviewed and aggregated where necessary to prevent the possibility of participant re-identification. Data Format: The data will be provided in standardized file formats such as Excel (.xlsx) to support compatibility and ease of use in secondary analyses. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal, informed consent form(s) and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Beginning 1 year after publication with no end date.

Locations