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Completed

NCT Number: NCT06480448

Treadmill Training Effects on Cardiorespiratory Endurance and Constipation in Children With Cerebral Palsy

This study examines the impact of treadmill training on cardiorespiratory endurance and constipation in children with cerebral palsy (CP). Treadmill training is evaluated for its potential to improve cardiovascular fitness and alleviate constipation through its rhythmic movements. The findings shed light on the broader health benefits of treadmill interventions beyond motor function improvement in children with CP

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Key information

Conditions

Cardiopulmonary

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehman Medical Institute

Peshawar, Punjab Province, 46000, Pakistan

About this study

This research investigates the effects of treadmill training on two distinct yet interconnected aspects of health in children with cerebral palsy (CP): cardiorespiratory endurance and constipation.

The research employs a longitudinal design, with participants undergoing a structured treadmill training program tailored to their individual needs and abilities. Outcome measures include objective assessments of cardiorespiratory fitness (e.g., exercise stress tests, spirometry) and subjective evaluations of constipation symptoms (e.g., bowel diaries, symptom questionnaires). Additionally, the study examines potential correlations between improvements in cardiorespiratory endurance and changes in constipation severity, exploring the interplay between physical fitness and gastrointestinal function in children with CP.

By investigating the effects of treadmill training on both cardiorespiratory endurance and constipation, this research aims to provide a comprehensive understanding of the broader health benefits associated with exercise interventions in children with cerebral palsy. The findings may inform the development of integrated rehabilitation programs that address multiple aspects of health and well-being in this population, ultimately improving overall quality of life and functional outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 4 to 12 years.
  • Children having 1, or 2 on GMFCM.
  • Children with spastic diplegic cerebral palsy.
  • Children with well cognitive behavior.
  • Children having 1 to 2 level on constipation assessment scale.
  • Defecation frequency less than 3 time a week.

Exclusion criteria

  • Misdiagnosed or not conform to Cerebral palsy.
  • Children should be medically stable uncontrolled seizures.
  • The children with mental retardation or other neurological disorders.
  • Children with taking medication like muscle relaxant or laxative

Treatment and study plan

Traditional physical herapy

Other

core stability, strengthening exercises, stationary bicycle training and sustained strechinng exercises.

Treadmill training

Other

Treadmill training for 20 minutes three time a week.

Primary outcomes

  1. Constipation Assessment Scale (CAS)

    Time frame: Baseline - 12th Week

    One commonly used tool for assessing constipation in children is the "Rome IV Criteria," which is part of the Rome IV diagnostic criteria for functional gastrointestinal disorders. These criteria provide a standardized framework for diagnosing constipation based on specific symptoms and duration requirements

  2. 6-mintues walk test

    Time frame: Baseline - 12th Week

    The 6-Minute Walk Test (6MWT) is a standardized assessment used to measure a person's functional exercise capacity and endurance. During the test, individuals are instructed to walk as far as they can within a six-minute period along a flat, straight course. The test is typically conducted in a corridor or along a marked pathway, and the distance covered is recorded at the end of the test.

    Before the test begins, participants receive instructions on the procedure and are given the opportunity to ask questions. Baseline measurements such as heart rate, blood pressure, and oxygen saturation may be taken. Participants are encouraged to walk at a self-selected pace, and they are allowed to rest if needed during the test. However, the timer continues to run during rest periods.

  3. Heart Rate

    Time frame: Baseline - 12th Week

    The number of pulses over a minute is the standard heart rate measurement. This can also be calculated by doubling the number of pulses felt over 30 seconds.

  4. VO2 Max

    Time frame: Baseline - 12th Week

    VO2 max, or maximal oxygen consumption, refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. This measurement is generally considered the best indicator of cardiovascular fitness and aerobic endurance.

  5. Respiratory Rate

    Time frame: Baseline - 12th Week

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Treadmill Training on Cardio Respiratory Endurance and Constipation in Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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