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The effect of cough assist and inspiratory muscle training in patients with NMD

The effect of mechanical insufflation-exsufflation and inspiratory muscle training on clinical outcomes and health-related quality of life in paediatric and adolescent patients with neuromuscular diseases presenting with respiratory muscle weakness: a multi-centre trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201506001171421
Enrollment
88
Registered
2015-06-10
Start date
2015-11-30
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases Respiratory Paediatrics Neuromuscular diseases

Interventions

Inspiratory muscle training
Standard care
Manual assisted coughing

Sponsors

Anri Human
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: MI-E study: Documented diagnosis of any congenital or paediatric/adolescent NMD. Patients admitted for acute respiratory infections and/or respiratory complications such as increased work of breathing, respiratory muscle fatigue, orthopnoea, retention of secretions/inability to clear secretions, decreased peak expiratory cough flow. IMT study: Documented diagnosis of any congenital or paediatric/adolescent NMD. Patients admitted for acute respiratory infections and/or respiratory complications such as increased work of breathing, respiratory muscle fatigue, orthopnoea, retention of secretions/inability to clear secretions, decreased peak expiratory cough flow.

Exclusion criteria

Exclusion criteria: MI-E study: Unstable vital signs such as resting arterial O2 saturation (SpO2) of 7kPa on the day of recruitment. If the vital signs should stabilise within the following 48 hours, patients will be reconsidered for inclusion. If patients are terminally ill, have bullae emphysema, scoliosis > 100 degrees (La Place¿s Law) or cannot cooperate/follow basic instructions. Previous history of a pneumothorax/ pneumo-mediastinum, recent (< 6months) barotrauma, thoracic/abdominal surgery. Patient that present with cardiac failure (confirmed by a physician). Patient that are participating in the IMT study, as this might influence their reaction to MI-E treatment as well as their clinical outcomes. Patients that are unable to cooperate/comply with the cough assist technique(s). IMT study: Patients that are terminally ill. Patients with <25% predicted value VC will be excluded. Patients that are unable to cooperate/comply with the training programme.

Design outcomes

Primary

MeasureTime frame
Duration of hospital stay;Ventilatory support;Supplemental oxygen;Respiratory infections requiring antibiotics (frequency);Hospital admissions (frequency);Patient's functional ability

Secondary

MeasureTime frame
Disease severity scale;Vital signs: respiratory rate, heart rate, oxygen saturation, blood gases if available (PaO2, PaCO2 and FiO2);Pulmonary function tests (VC, FVC, FEV1 and TLC);Cough efficacy (PECF);Comfort of breathing (VAS);Comfort of cough augmentation technique (MAC vs MI-E) (VAS);Vital signs: respiratory rate, heart rate, oxygen saturation, blood gases if available (PaO2, PaCO2 and FiO2);Pulmonary function tests (VC, FVC, FEV1 and TLC);Cough efficacy (PECF);Inspiratory muscle strength (SNIP);Inspiratory muscle strength (PImax);Inspiratory muscle strength (PImax);Health-related quality of life (PedsQL)

Countries

South Africa

Contacts

Public ContactAnri Human

Lecturer

anrihuman@gmail.com012 521-4047

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026