-To describe the differences in the parameters of physical exertion during physical activity with two different HMEs in both a lab and daily life setting-To asses patients* satisfaction with both types of HMEs
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
- Upper respiratory tract disorders (excl infections)
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-The changes in heart rate (HR) and respiratory rate (RR) relative to physical
activity levels in daily life activities
-Changes in VO2 uptake and CO2 clearance from gas analysis during submaximal
exercise testing
-Self-reported measures of satisfaction and comfort (questionnaires), and Borg
scale for perceived levels of exertion during exercise testing
Secondary outcome
Not applicable
Background summary
Members of this study population are less likely to meet daily exercise
guidelines for a multitude of reasons, one of which being the breathing
resistance imposed by heat and moisture exchangers (HMEs). With the Energy HME,
which has a goal of reducing breathing resistance during physical activity, the
hope is to make physical activity more attainable for laryngectomized
individuals. This study aims to asses how the parameters of physical exertion
vary during day to day physical activities as well as during more intensive
bouts of physical activity in individuals using an HME, and to explore how
these parameters differ when using the Energy HME as compared to an
individual*s regularly used HME. With physical activity more comfortable and
doable for individuals, it will be possible to design more effective exercise
training in the future and therefore enhance the overall health of this
population.
Study objective
-To describe the differences in the parameters of physical exertion during
physical activity with two different HMEs in both a lab and daily life setting
-To asses patients* satisfaction with both types of HMEs
Study design
Prospective, single group randomized cross-over observational study
Intervention
All included subjects will participate in all testing conditions. They will
undergo submaximal exercise testing as well as observation for extended periods
using 2 different HME models: their regular daily HME and the Energy HME.
Study burden and risks
We do not foresee any risks to be associated with this study as both treatment
conditions have undergone the individual approval process and will be used
according to their intended use. There is burden on the participants as they
will be required to attend 4 appointments, fill out questionnaires on 3
separate occasions, participate in submaximal exercise testing, wear a
heartrate and physical activity monitoring device, and change out monitoring
devices on 3 separate occasions.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
* Undergone a total laryngectomy
* Be a daily HME user
* Maintain a fairly active lifestyle
* Be proficient in Dutch
Exclusion criteria
* Lead a sedentary life
* Are wheelchair bound
* Have known cardiac issues
* Lack of access to WIFI in the home
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72840.031.20 |