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Inspiratory Muscle Training in Cerebral Palsy Patients

Primary Purpose

Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring rehabilitation, respiration, fatigue, breathing exercise, physical capacity

Eligibility Criteria

3 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cerebral palsy patients
  • Understand the objectives and be able to complete questionaires

Exclusion Criteria:

  • Respiratory pathology during the 4 weeks prior the start of the study
  • Any complication that may impeded the performance of the evaluation tests or breathing techniques

Sites / Locations

  • Carlos Martin Sanchez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High intensity group

Low intensity group

Arm Description

Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.

Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
Maximal expiratory pressure
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.

Secondary Outcome Measures

Dyspnea
The Borg scale of perceived exertion. Minimum value = 0, Maximum value = 10. Higher scores mean a better outcome.

Full Information

First Posted
May 31, 2021
Last Updated
June 5, 2021
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT04915170
Brief Title
Inspiratory Muscle Training in Cerebral Palsy Patients
Official Title
Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in cerebral palsy patients to improve respiratory strength, spirometric parameters and dyspnea. Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); functional capacity measured with 6 minute walk test; dyspnea using the Borg scale 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 days/week 15 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.
Detailed Description
Participants: Adult cerebral palsy patients. 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 doesn´t meet any of the participants until the initial assessment will be carried out. Evaluation: The participants are evaluated at the beginning and end of the intervention period. The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which obtains each measurement in millibar and converts it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O .), following the rules of the American thoracic society/European respiratory society (ATS / ERS). The procedure will be repeated until 3 values were obtained with a difference of less than 5%, and the highest value will be used for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the IMT workload. Lung volumes are assessed using a spirometer (model: datospir touch) with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will be followed [19], and the highest value of three correct measurements will be chosen. Data is collected for the following parameters: maximum voluntary ventilation (MVV), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC). Dyspnea will be measured using the modified Borg scale [20]. Functional capacity will be measured with 6 minute walk test. All evaluations will be done in the corresponding center, during the same time slot and by the same examiner for both groups. 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 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve. "Low-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 20% of MIP. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
rehabilitation, respiration, fatigue, breathing exercise, physical capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
Masking
ParticipantInvestigator
Masking Description
The principal investigator doesn´t know the group of the patients until the study ends
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity group
Arm Type
Experimental
Arm Description
Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.
Arm Title
Low intensity group
Arm Type
Experimental
Arm Description
Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O)
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure
Description
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
Time Frame
2 minutes
Title
Maximal expiratory pressure
Description
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Dyspnea
Description
The Borg scale of perceived exertion. Minimum value = 0, Maximum value = 10. Higher scores mean a better outcome.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral palsy patients Understand the objectives and be able to complete questionaires Exclusion Criteria: Respiratory pathology during the 4 weeks prior the start of the study Any complication that may impeded the performance of the evaluation tests or breathing techniques
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CARLOS MARTIN SANCHEZ, PhD
Phone
+34646774655
Email
carlos_ms@usal.es
Facility Information:
Facility Name
Carlos Martin Sanchez
City
Salamanca
ZIP/Postal Code
37006
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARLOS MARTIN-SANCHEZ, PHD
Phone
646774655
Email
carlos_ms@usal.es

12. IPD Sharing Statement

Plan to Share IPD
No

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Inspiratory Muscle Training in Cerebral Palsy Patients

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