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Completed

NCT Number: NCT04915170

Inspiratory Muscle Training in Cerebral Palsy Patients

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.

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Key information

Conditions

Respiratory Insufficiency Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Motor Activity Nervous System Diseases Respiration Disorders Respiratory Tract Diseases

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carlos Martin Sanchez

Salamanca, 37006, Spain

About this study

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 doesn´t 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 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

the presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate > 150 beats per minute (bpm), systolic blood pressure > 140 millimeters mercury (mmHg) or diastolic blood pressure > 90 mmHg).

Treatment and study plan

Inspiratory muscle training

Device

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

Primary outcomes

  1. Maximal inspiratory pressure

    Time frame: 2 minutes

    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. Maximal expiratory pressure

    Time frame: 2 minutes

    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 outcomes

  1. Pulmonary volume

    Time frame: 1 minute

    The evaluation is performed collecting forced expiratory volume in 1 second (FEV1). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England)

  2. Pulmonary flow

    Time frame: 1 minute

    The evaluation is performed collecting peak expiratory flow (PEF). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England)

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2021
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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