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

Completed

Conditions: Stemproblemen
Pulmonary functioning
reduced cough strength
10046304

Registration Number: NL-OMON45719

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maximum Expiratory Pressure en Peak Expiratory Flow.</p><br>

Secondary Outcome Measures

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