'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
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|ClinicalTrials.gov Identifier: NCT04419792|
Recruitment Status : Suspended (Recruitment for study has been suspended due to Covid-19.)
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
|Condition or disease||Intervention/treatment|
|Narcolepsy Narcolepsy 1 Narcolepsy Type 1 Narcolepsy With Cataplexy Narcolepsy Without Cataplexy Narcolepsy and Hypersomnia Hypersomnolence||Other: Assessment of physical performance variables|
This study aims to profile the physical functioning variables of people with narcolepsy attending an outpatient clinic at St. James's Hospital. This will be accomplished by ascertaining the cardiopulmonary fitness, physical activity, and muscle strength and endurance of this population.
Secondary objectives of this study will be to explore the relationship between physical performance indices and sleep quality, functional ability and quality of life in this population.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'|
|Actual Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Other: Assessment of physical performance variables
Assessment of physical performance indices using the following outcome measures:
Cardiopulmonary fitness: YMCA submaximal bike test Upper Body: ACSM press up test, Dynamometry Lower body: Wall squat test, Countermovement jump test
- Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted) [ Time Frame: 30 minutes ]The submaximal Young Men's Christian Association (YMCA) exercise test utilises the relationship between workload and heart rate to predict maximal oxygen consumption. Provides indication of cardiopulmonary fitness.
- Measurement of grip strength [ Time Frame: 15 minutes ]Objective measure of grip strength of the dominant and non-dominant hands, and will provided indication of how grip strength compares to age and gender-matched norms. Dynamometry will be used to asses muscle strength of the upper limb.
- Measurement of upper limb endurance [ Time Frame: 10 minutes ]The American College of Sports Medicine Press Up Test will be used to objectively measure muscular endurance of the upper limb. Identifies the maximum number of press ups that the participant can perform before failure.
- Measurement of lower limb endurance [ Time Frame: 10 minutes ]The wall sit test will be used to objectively measure lower limb endurance. Measures the duration a participant can maintain a wall sit until failure.
- Measurement of lower limb power. [ Time Frame: 10 minutes ]The Countermovement Jump Test will be used to objectively measure lower limb power. This test measures both jump height and peak power achieved by participants.
- Measurement of physical activity [ Time Frame: 7 days ]Actigraphy will be used to objectively measure physical activity and sedentary behaviour. Participant will be required to wear the actigraph around their waist during all waking hours except during swimming or bathing, and then send back to assessor in return-addressed envelopes.
- Subjective measure of Health-Related Quality of Life [ Time Frame: 10 minutes ]Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).
- Subjective measure of Health-Related Quality of Life (sleep-disorder-specific) [ Time Frame: 10 minutes ]Health-related quality of life will be subjectively assessed using the Functional Outcomes of Sleep Questionnaire questionnaires
- Subjective measure of symptom severity [ Time Frame: 10 minutes ]Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.
- Subjective measure of daytime sleepiness [ Time Frame: 5 minutes ]Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.
- Subjective measure of physical activity [ Time Frame: 5 minutes ]Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.
- Subjective measure of sedentary behaviour [ Time Frame: 5 minutes ]Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419792
|Department of Physiotherapy, School of Medicine, Trinity College Dublin|
|Dublin, Ireland, D08 W9RT|