Clinical trial NCT04915170: Inspiratory Muscle Training in Cerebral Palsy Patients
Official title: Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: aging
cerebral palsy
MANOVA
muscle strength
older adults
physical activity
respiratory exercises
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 38
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Maximal inspiratory pressure
timeFrame: 2 minutes
measure: Maximal expiratory pressure
timeFrame: 2 minutes
Secondary outcomes:
measure: Pulmonary volume
timeFrame: 1 minute
measure: Pulmonary flow
timeFrame: 1 minute
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Carlos Martin Sanchez
Study officials:
affiliation: University of Salamanca
name: CARLOS MARTIN SANCHEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: