CClinicalTrials.gg
CompletedNCT06480448Updated Jan 13, 2025

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

An interventional study of Traditional physical herapy and Treadmill training in Cardiopulmonary, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cardiopulmonary

Keywords

  • motor function
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 36 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
36 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherTraditional physical herapy

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

  • OtherTreadmill training

    Treadmill training for 20 minutes three time a week.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline - 12th Week

  2. 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.

    Time frame: Baseline - 12th Week

  3. 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.

    Time frame: Baseline - 12th Week

  4. 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.

    Time frame: Baseline - 12th Week

  5. Respiratory Rate

    Time frame: Baseline - 12th Week

07

Study locations

1 site
  • Rehman Medical Institute
    Peshawar, Punjab 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06480448
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 28, 2024
Start date
Apr 28, 2024
Primary completion
Dec 30, 2024
Completion
Dec 31, 2024
Last update
Jan 13, 2025

Study contacts

Waqar Ahmed Awan, PhD
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion