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The effectiveness of device-driven Expiratory Muscle Strength Training (EMST) in total laryngectomy patients; A pilot study.

The effectiveness of device-driven Expiratory Muscle Strength Training (EMST) in total laryngectomy patients; A pilot study. - EMST in total laryngectomy patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45719
Enrollment
12
Registered
2017-02-27
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Stemproblemen Pulmonary functioning reduced cough strength

Interventions

Group 1 (n=6) Four weeks of EMST-training, four weeks no training. Group 2 (n=6) Four weeks of EMST-training, four weeks continued training on maintainence dose. Both groups perform the first four we

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years or older Male Undergone TL At least 6 months post TL At least 6 months post-operative (chemo)radiotherapy Signed informed consent

Exclusion criteria

Exclusion criteria: Currently undergoing chemotherapy +/- radiation therapy Positive past history of lung cancer or tuberculosis Reoccurrence of head and neck cancer History of abdominal hernia Uncontrolled or untreated hypertention No heart attack in the previous year Unable to understand the patient information. Unable to comprehend and use of the device (e.g. Alzheimer* s disease, Korsakov). Physically unfit to use the device (e.g. neurological deficit). Unwilling or unable to provide informed consent or do not possess the ability or willingness to comply with study-related procedures.

Design outcomes

Primary

MeasureTime frame
Maximum Expiratory Pressure en Peak Expiratory Flow.

Secondary

MeasureTime frame
Spirometry which revelas Vital capacity (VC), forced expiratory volume in the first second (FEV1) and, mean expiratory flow (MEF). Cardio Pulmonary Exercise Test (CPET) which includeds measurements of breath-by-breath minute ventilation (VE), oxygen uptake (VO2), carbon dioxide production (VCO2), and RER (VCO2/VO2). Voice recordings to obtain maximum phonation time (sec) and range in Hz (high - low) and dB (soft - loud). Borg Ratings of Perceived Exertion Modified Borg Dyspnoea Scale Short Fatigue questionnaire Linear Analogue Self Assessments Clinical COPD Questionnaire Voice Handicap Index 10 item version Study specific questions

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)