CardiopulmonaryNCT06480448
Treadmill Training Effects on Cardiorespiratory Endurance and Constipation in Children With Cerebral Palsy
A study testing Traditional physical herapy and Treadmill training in people with Cardiopulmonary, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cardiopulmonary
- What is being tested?
- Traditional physical herapy and Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Cardiopulmonary
- Being tested
- Traditional physical herapy, Treadmill training
- Keywords
- motor function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical herapyOther
core stability, strengthening exercises, stationary bicycle training and sustained strechinng exercises.
Treadmill trainingOther
Treadmill training for 20 minutes three time a week.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy | Experimental | This group will only getting conventional therapy which include core stability training, strength training, gait training through Parallel bar etc. Receives: Other: Traditional physical herapy |
| Treadmill training | Active comparator | 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. Receives: Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline - 12th Week
Respiratory Rate
Measured: Baseline - 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start28 Apr 2024
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiopulmonaryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmed Awan, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480448
- Sponsor's protocol ID
- RIPHAH/FR&AHS/letter-01826
- Status last verified
- Jan 2025
- First submitted
- 29 Apr 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treadmill Training on Cardio Respiratory Endurance and Constipation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06480448
- Acronym / sponsor ID
- RIPHAH/FR&AHS/letter-01826
- Conditions
- Cardiopulmonary
- Keywords
- motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy | Experimental | Other: Traditional physical herapyThis group will only getting conventional therapy which include core stability training, strength training, gait training through Parallel bar etc. |
| Treadmill training | Active comparator | Other: Treadmill trainingThis 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional physical herapycore stability, strengthening exercises, stationary bicycle training and sustained strechinng exercises. | Other | Traditional physical therapy |
| Treadmill trainingTreadmill training for 20 minutes three time a week. | Other | Treadmill training |
Primary outcome
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
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.
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.
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.
Respiratory Rate
Time frame: Baseline - 12th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
Cardiopulmonary Bypass, Obese Patients
RecruitingPhase 2/3
The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqar Ahmed Awan, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical herapy and Treadmill training in people with Cardiopulmonary, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Assessment Scale (CAS) (time frame: Baseline - 12th Week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.