Inspiratory Muscle Training in Cerebral Palsy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The principal investigator doesn´t know the group of the patients until the study ends

Study Groups

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High intensity group

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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type DEVICE

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

Low intensity group

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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type DEVICE

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

Interventions

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