Long Term Effects of Inspiratory Muscle Training in Cerebral Palsy

NCT06064292 | Completed

• 1 other identifier: 21032023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Cerebral Palsy; Muscle Weakness; Older People--Abuse of; Physical Inactivity; Respiratory Tract Problem

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle strength

  Maximum inspiratory pressure (MIP), unit of measure, Centimeters of water (cmH2O).

  8 weeks.

Secondary Outcomes (3)

• Expiratory muscle strength

  8 WEEKS

• Respiratory volume

  8 Weeks

• Respiratory flow

  8 weeks.

Study Arms (2)

The High Intensity Training Group (HIT)

EXPERIMENTAL

The High Intensity Training Group (HIT) received IMT at 40% of Maximum Inspiratory Pressure (MIP), the training load was set each 2 weeks to keep 40% of MIP.

Device: INSPIRATORY MUSCLE TRAINING

The Low Intensity Training Group (LIT)

EXPERIMENTAL

The Low Intensity Training Group (LIT) received IMT at 20% of MIP, following the same rules as HIT.

Device: INSPIRATORY MUSCLE TRAINING

Interventions

INSPIRATORY MUSCLE TRAINING DEVICE

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.

The High Intensity Training Group (HIT); The Low Intensity Training Group (LIT)

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Institutionalized adults with cerebral palsy

You may not qualify if:

• The presence of a respiratory disease in the previous month
• Inability to understand assessment tests or intervention
• Hemodynamic alterations (heart rate \> 150 beats per minute (bpm), systolic blood pressure \> 140 millimeters mercury (mmHg) or diastolic blood pressure \> 90 mmHg).

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, 37008, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Weakness; Sedentary Behavior

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Carlos Martin Sanchez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: . The professional that collected the data and the participants were unaware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 3, 2023
• Study Start: March 21, 2023
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)