Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04915170
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2021-05-31
Brief Title:
Inspiratory Muscle Training in Cerebral Palsy Patients
Sponsor:
University of Salamanca
Organization:
University of Salamanca
Study Overview
Official Title:
Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effectiveness of two protocols of inspiratory muscle training IMT in cerebral palsy patients to improve respiratory strength and spirometric parameters Low-intensity vs high-intensity resistance training programs Evaluations Determination of the maximum inspiratory pressure MIP and the maximum expiratory pressure MEP spirometry - peak expiratory flow PEF forced expiratory volume in first second FEV1 and clinical evaluations The participants will be evaluated at the beginning and end of the intervention period Intervention There are two groups of patients one works with low loads 20 MIP and another with high loads 40 MIP They train 5 daysweek 10 cycles lasting 1 minute There is a rest of 1 minute between each cycle
Detailed Description:
The study was a controlled randomised double-blind trial and with allocation concealment The study protocol was approved by the Bioethics Committee of the University of Salamanca number of registry 678 6th October 2021
Participants
Institutionalized people with cerebral palsy between 35 and 64 years were included they were all members of ASPACE Salamanca
All patients will be asked to carry out the 5-day weekly program and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session All participants signed an informed consent form
The patients will be assigned to the two groups randomly The main researcher doesnt meet any of the participants until the initial assessment will be carried out
Intervention
High-intensity group The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting in cm H2O
The intensity of the device will be 40 of MIP The protocol includes 10 cycles lasting 1 minute The participants rest for 1 minute between each cycle In total the protocol includes 10 minutes of daily respiratory training The patients will be instructed to inhale with enough force to reach the opening of the valve
Low-intensity groupThe device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting in cm H2O
The intensity of the device will be 20 of MIP The protocol includes 10 cycles lasting 1 minute The participants rest for 1 minute between each cycle In total the protocol includes 10 minutes of daily respiratory training The patients will be instructed to inhale with enough force to reach the opening of the valve
Participants
Institutionalized people with cerebral palsy between 35 and 64 years were included they were all members of ASPACE Salamanca
All patients will be asked to carry out the 5-day weekly program and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session All participants signed an informed consent form
The patients will be assigned to the two groups randomly The main researcher doesnt meet any of the participants until the initial assessment will be carried out
Intervention
High-intensity group The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting in cm H2O
The intensity of the device will be 40 of MIP The protocol includes 10 cycles lasting 1 minute The participants rest for 1 minute between each cycle In total the protocol includes 10 minutes of daily respiratory training The patients will be instructed to inhale with enough force to reach the opening of the valve
Low-intensity groupThe device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting in cm H2O
The intensity of the device will be 20 of MIP The protocol includes 10 cycles lasting 1 minute The participants rest for 1 minute between each cycle In total the protocol includes 10 minutes of daily respiratory training The patients will be instructed to inhale with enough force to reach the opening of the valve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None