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

Effects of Treadmill Training on Cardio Respiratory 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

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary
• Intervention / Treatment: Other: Traditional physical herapy; Other: Treadmill training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Peshawar, Punjab, Pakistan, 46000
      • Rehman Medical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional physical therapy; This group will only getting conventional therapy which include core stability training, strength training, gait training through Parallel bar etc.	Other: Traditional physical herapy; core stability, strengthening exercises, stationary bicycle training and sustained strechinng exercises.
Active Comparator: Treadmill training; This group will getting treadmill training will be started along with conventional therapy group. Training protocol will be standardized and follow FITT protocol for 12 weeks.	Other: Treadmill training; Treadmill training for 20 minutes three time a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation Assessment Scale (CAS)	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	Baseline - 12th Week
6-mintues walk test	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.	Baseline - 12th Week
Heart Rate	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.	Baseline - 12th Week
VO2 Max	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.	Baseline - 12th Week
Respiratory Rate		Baseline - 12th Week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Waqar Ahmed Awan, PHD, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: motor function
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Brain Damage, Chronic; Cerebral Palsy; Constipation
• Other Study ID Numbers: RIPHAH/FR&AHS/letter-01826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No