Inspiratory Muscle Training in Adults With Cerebral Palsy: Long Term Effects. A Double-blind Randomised Controlled Trial

Study design The study was a controlled, randomised, double-blind trial and with allocation concealment. The Bioethics Committee of the University of Salamanca affirms that the study meets ethical requirements for its execution (registry number 678)

Participants Institutionalized adults with CP aged between 35 and 64 years were included in the study, they were all members of ASPACE Salamanca. 38 patients with CP were selected to participate in the study. 27 participants were voluntarily recruited to participate in respiratory training and randomly distributed in the High Intensity Training Group (HIT) or Low Intensity Training Group (LIT).

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).

The sample size was established by sampling calculation done from collected during a pilot study with 10 volunteers, which determined a minimum of 10 patients for each group to perceive differences of 12 cmH2O for MIP, power of 80%, security of 95%.

Procedures and Measures of Outcomes Elderly people with cerebral palsy were randomly allocated, via computerized random assignment, to either a high intensity intervention group or a low intensity intervention group. The professional that collected the data and the participants were unaware of group assignment. Before (pre-intervention) and after (post-intervention) inspiratory muscle training, respiratory muscle strength and pulmonary function were evaluated. Once the intervention period phase ended, 3 more evaluations of the same parameters were mare, the first at 4 weeks, the second at 12 weeks and the third at 24 weeks after finishing IMT.