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Long Term Effects of Inspiratory Muscle Training in Cerebral Palsy

NCT06064292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

DEVICE

INSPIRATORY MUSCLE TRAINING

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.

Sponsors & Collaborators

  • University of Salamanca

    lead OTHER

Principal Investigators

  • Carlos Martin Sanchez, PhD · University of Salamanca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2023-09-21
Completion
2023-09-21

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06064292 on ClinicalTrials.gov