Inspiratory Muscle Training in Cerebral Palsy Patients
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency; Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Device
Intervention description(s): The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: aging; cerebral palsy; MANOVA; muscle strength; older adults; physical activity; respiratory exercises