Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06064292
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2023-09-21
Brief Title:
Long Term Effects of Inspiratory Muscle Training in Cerebral Palsy
Sponsor:
University of Salamanca
Organization:
University of Salamanca
Study Overview
Official Title:
Inspiratory Muscle Training in Adults With Cerebral Palsy Long Term Effects A Double-blind Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Respiratory disease is one of the main causes of morbidity and mortality in adults with cerebral palsy CP Adequate pulmonary function is essential to prevent these health problems however respiratory muscle training has not yet been studied in CP patients The main objective of the study was to investigate the maintenance over time of improvements in respiratory parameters achieved with inspiratory muscle training IMT
Methods This was a controlled randomised double-blind trial and with allocation concealment performed on 27 institutionalized CP patients randomly distributed in 2 groups high intensity training group HIT and low intensity training group LIT Participants followed a specific IMT program for 8 weeks HIT workload was 40 of maximum inspiratory pressure MIP and LIT workload was 20 MIP Once finished 8-week training period CP patients continued their daily activities Respiratory muscle strength and pulmonary function were measured pre-IMT post-IMT 4 12 and 24 weeks after finishing IMT
Methods This was a controlled randomised double-blind trial and with allocation concealment performed on 27 institutionalized CP patients randomly distributed in 2 groups high intensity training group HIT and low intensity training group LIT Participants followed a specific IMT program for 8 weeks HIT workload was 40 of maximum inspiratory pressure MIP and LIT workload was 20 MIP Once finished 8-week training period CP patients continued their daily activities Respiratory muscle strength and pulmonary function were measured pre-IMT post-IMT 4 12 and 24 weeks after finishing IMT
Detailed Description:
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
Primary outcome The primary outcome was respiratory muscle strength measured pre-IMT post-IMT and 4 12 and 24 weeks after finishing IMT intervention It was evaluated through maximum inspiratory pressure MIP and maximum expiratory pressure MEP using a pressure measurer Elka PM-15 Laboliser SA Barcelona Spain from residual volume and total lung capacity severally Each measure was expressed in millibars and turned into centimeter of water reference unit cm H2O 1 mbar 101973 cm H2O according to recommendations of the American Thoracic SocietyEuropean Respiratory Society ATS ERS 24 Each test was repeated 3 times or until 2 valid results were obtained difference less than 5 A rest time of 1 minute was respected between efforts to prevent short-term respiratory muscle fatigue The highest value was selected MIP was evaluated every 2 weeks to graduate the load of the device training
Secondary outcome The secondary outcome was pulmonary function measured pre-IMT post-IMT and 4 12 and 24 weeks after finishing IMT intervention The data collected were forced expiratory volume in 1 second FEV1 and peak expiratory flow PEF It was measured using the peak flow device Asma-1 Vitalograph Ltd Buckingham England that expresses the results of FEV1 in liters L and PEF in liters per minute Lmin according to the guidelines of the ATSERS
Experimental Protocol Inspiratory muscle training was carried out with a pressure threshold device Treshold IMT Philips-Respironics Pittsburg PA USA Threshold IMT provides consistent and specific pressure for inspiratory muscle strength and endurance training regardless of how quickly or slowly patients breathe This device incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting in cm H2O to be set by a healthcare professional When patients inhale through Threshold IMT a spring-loaded valve provides resistance Before training began the participants and primary caregivers completed one-session familiarization with a specialist to learn how to operate the device
Adult people with cerebral palsy carried out the training program for 8 weeks 1 session every day 5 days a week The participants performed 10 series of 1 minute with 1-minute rest between them
The High Intensity Training Group HIT received IMT at 40 of MIP the training load was set each 2 weeks to keep 40 of MIP The Low Intensity Training Group LIT received IMT at 20 of MIP following the same rules as HIT
The training protocols of the two groups were developed by a specialist in respiratory therapy and all sessions with IMT were supervised by their main caregiver therefore adherence to the program was controlled as well as possible unwanted effects increased fatigue breathing problems dizziness or sickness
During the intervention period both groups continued with their usual activity receiving physiotherapy treatment for 45 minutes per day 2 days per week No participants received any other treatments
After finishing the 8-week intervention period with IMT CP patients stopped training with IMT and continued with their daily normal activities During the following 24 weeks without IMT three evaluations of the respiratory parameters analyzed in the trial were made MIP MEP FEV1 PEF The first evaluation was made 4 weeks after the intervention was completed the second 12 weeks and the third 24 weeks after finishing IMT
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
Primary outcome The primary outcome was respiratory muscle strength measured pre-IMT post-IMT and 4 12 and 24 weeks after finishing IMT intervention It was evaluated through maximum inspiratory pressure MIP and maximum expiratory pressure MEP using a pressure measurer Elka PM-15 Laboliser SA Barcelona Spain from residual volume and total lung capacity severally Each measure was expressed in millibars and turned into centimeter of water reference unit cm H2O 1 mbar 101973 cm H2O according to recommendations of the American Thoracic SocietyEuropean Respiratory Society ATS ERS 24 Each test was repeated 3 times or until 2 valid results were obtained difference less than 5 A rest time of 1 minute was respected between efforts to prevent short-term respiratory muscle fatigue The highest value was selected MIP was evaluated every 2 weeks to graduate the load of the device training
Secondary outcome The secondary outcome was pulmonary function measured pre-IMT post-IMT and 4 12 and 24 weeks after finishing IMT intervention The data collected were forced expiratory volume in 1 second FEV1 and peak expiratory flow PEF It was measured using the peak flow device Asma-1 Vitalograph Ltd Buckingham England that expresses the results of FEV1 in liters L and PEF in liters per minute Lmin according to the guidelines of the ATSERS
Experimental Protocol Inspiratory muscle training was carried out with a pressure threshold device Treshold IMT Philips-Respironics Pittsburg PA USA Threshold IMT provides consistent and specific pressure for inspiratory muscle strength and endurance training regardless of how quickly or slowly patients breathe This device incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting in cm H2O to be set by a healthcare professional When patients inhale through Threshold IMT a spring-loaded valve provides resistance Before training began the participants and primary caregivers completed one-session familiarization with a specialist to learn how to operate the device
Adult people with cerebral palsy carried out the training program for 8 weeks 1 session every day 5 days a week The participants performed 10 series of 1 minute with 1-minute rest between them
The High Intensity Training Group HIT received IMT at 40 of MIP the training load was set each 2 weeks to keep 40 of MIP The Low Intensity Training Group LIT received IMT at 20 of MIP following the same rules as HIT
The training protocols of the two groups were developed by a specialist in respiratory therapy and all sessions with IMT were supervised by their main caregiver therefore adherence to the program was controlled as well as possible unwanted effects increased fatigue breathing problems dizziness or sickness
During the intervention period both groups continued with their usual activity receiving physiotherapy treatment for 45 minutes per day 2 days per week No participants received any other treatments
After finishing the 8-week intervention period with IMT CP patients stopped training with IMT and continued with their daily normal activities During the following 24 weeks without IMT three evaluations of the respiratory parameters analyzed in the trial were made MIP MEP FEV1 PEF The first evaluation was made 4 weeks after the intervention was completed the second 12 weeks and the third 24 weeks after finishing IMT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None