Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Salamanca
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Maximal inspiratory pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The principal investigator doesn´t know the group of the patients until the study ends
Eligibility Criteria
- Ages
- 35 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Inspiratory muscle training (Device)
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.
Intervention: Inspiratory muscle training (Device)
Outcomes
Primary Outcomes
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.
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
- Pulmonary flow(1 minute)
- Pulmonary volume(1 minute)
Investigators
CARLOS MARTIN SANCHEZ
Principal Investigatr
University of Salamanca