Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02710110
• Date of registration: 26/02/2016
• Prospective Registration: Yes
• Primary sponsor: University of Florida
• Public title: Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: April 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02710110
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Emily K Plowman, Ph.D.
• Affiliation: University of Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS),

- Amyotrophic Lateral Sclerosis Rating Scale Revised score greater than 34,

- forced vital capacity greater than 70%,

- cognition within normal limits as determined by Montreal assessment of cognition score
>25

Exclusion Criteria:

- allergies to barium,

- tracheotomy or mechanical ventilation,

- diaphragmatic pacer,

- concurrent respiratory disease (e.g. COPD),

- pregnant at the time of the study due to radiation exposure



Age minimum: 21 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Other: Swallowing Quality of Life Questionnaire

Device: Iowa Oral Pressure Instrument

Device: PowerLung trainer

Procedure: Pulmonary Function Testing

Device: Micro Mouth Pressure Meter

Drug: Capsaicin

Procedure: Videofluoroscopic swallowing study

Primary Outcome(s)

Pulmonary function to measure the peak expiratory flow (PEF) will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Maximum Inspiratory Pressure will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Sniff Nasal Inspiratory Pressure will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Pulmonary function to measure the forced expiratory volume (FEV1) will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Maximum Expiratory Pressure will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Pulmonary function to measure the forced vital capacity (FVC) between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Secondary Outcome(s)

Lingual endurance will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

The Penetration-aspiration scale will be used to measure swallowing function [Time Frame: Changes from baseline to month 3]

Lingual strength will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Voluntary cough function will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Reflexive cough will be measured between the groups for a change from baseline to month 3 [Time Frame: Changes from baseline to month 3]

Secondary ID(s)

IRB201501172

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ALS Association