NCT04915170

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 days/week 10 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

May 31, 2021

Last Update Submit

February 8, 2024

Conditions

Respiratory Insufficiency

Keywords

agingcerebral palsyMANOVAmuscle strengtholder adultsphysical activityrespiratory exercises

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 minutes

  • 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.

    2 minutes

Secondary Outcomes (2)

  • Pulmonary volume

    1 minute

  • Pulmonary flow

    1 minute

Study Arms (2)

High intensity group

EXPERIMENTAL

Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 10 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.

Device: Inspiratory muscle training

Low intensity group

EXPERIMENTAL

Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 10 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.

Device: Inspiratory muscle training

Interventions

Inspiratory muscle trainingDEVICE

The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O)

High intensity groupLow intensity group

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlos Martin Sanchez

Salamanca, 37006, Spain

Location

Related Publications (1)

  • Martin-Sanchez C, Barbero-Iglesias FJ, Amor-Esteban V, Martin-Sanchez M, Martin-Nogueras AM. Inspiratory Muscle Training in Adults With Cerebral Palsy: Long Term Effects: A Double-Blind Randomized, Controlled Trial. Res Nurs Health. 2025 Oct;48(5):545-558. doi: 10.1002/nur.70000. Epub 2025 Jun 20.

    PMID: 40539466DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyCerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • CARLOS MARTIN SANCHEZ, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The principal investigator doesn´t know the group of the patients until the study ends
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigatr

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 7, 2021

Study Start

June 1, 2022

Primary Completion

August 1, 2022

Study Completion

February 1, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Data will be shared after approving.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After being published.
Access Criteria
Contact the corresponding author.

Locations

ES(1)