'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'

Narcolepsy Clinical Trial

Official title:

'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04419792
• Other study ID #: Cross Sectional
• Status: Suspended
• Start date: October 15, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2020
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Narcolepsy is a sleep disorder characterised by excessive daytime sleepiness and significantly impacts quality of life. People with narcolepsy demonstrate many potential barriers to being physically active, such as sleepiness and social isolation. Very little is known about how physical performance variables may be affected and influence disease experience in people with narcolepsy. This study aims to profile the physical fitness and physical functioning variables of adults with narcolepsy and to explore the relationship between physical variables, quality of life, symptom severity and disease experience in this cohort.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Est. completion date: September 30, 2020
• Est. primary completion date: May 31, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria for at least 6 months - diagnosis for at least 6 months will ensure that initial fluctuations due to likely starting on new drug regimen are relatively stable.

2. Eligibility screened and agreement of the participant's treating clinician in Narcolepsy out-patient clinic of St. James's Hospital that he/she can participate - to ensure that as per General Data Protection Regulation guidelines that the treating clinician eligibility screens rather than the physiotherapy study researcher.

3. Patients aged =18 to <65 years at the time of obtaining informed consent - as patients >18 years will not been seen in this centre, and patients >65 years may have age-related changes in cardiovascular fitness and physical activity which may be difficult to separate from those pertaining to narcolepsy diagnosis.

4. Able to understand English - as questionnaires will necessitate a sufficient level of English for completion.

Exclusion Criteria:

1. Patients with sleep disorders other than narcolepsy (e.g., moderate to severe sleep apnea syndrome, moderate to severe periodic limb movement disorder) - so results are not diluted by including conditions other than narcolepsy.

2. Any medical contraindication to exercise of moderate intensity and short duration including but not limited to cardiovascular or respiratory conditions, morbid obesity, and severe osteoarthritis of the lower extremities - as these conditions would preclude ability to conduct physical test battery.

3. Confirmed pregnancy - people with an advanced pregnancy may score differently on physical functioning/performance tests, people with a confirmed pregnancy will be excluded from study participation to limit bias.

4. Dementia or significant cognitive impairment or psychiatric illness that would preclude ability to participate in study.

Related Conditions & MeSH terms

• Cataplexy
• Disorders of Excessive Somnolence
• Hypersomnolence
• Narcolepsy
• Narcolepsy 1
• Narcolepsy and Hypersomnia
• Narcolepsy Type 1
• Narcolepsy With Cataplexy
• Narcolepsy Without Cataplexy

Intervention

Other:
• Assessment of physical performance variables
Other: 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

Locations

Country	Name	City	State
Ireland	Department of Physiotherapy, School of Medicine, Trinity College Dublin	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)	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.	30 minutes
Primary	Measurement of grip strength	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.	15 minutes
Primary	Measurement of upper limb endurance	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.	10 minutes
Primary	Measurement of lower limb endurance	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.	10 minutes
Primary	Measurement of lower limb power.	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.	10 minutes
Primary	Measurement of physical activity	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.	7 days
Secondary	Subjective measure of Health-Related Quality of Life	Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).	10 minutes
Secondary	Subjective measure of Health-Related Quality of Life (sleep-disorder-specific)	Health-related quality of life will be subjectively assessed using the Functional Outcomes of Sleep Questionnaire questionnaires	10 minutes
Secondary	Subjective measure of symptom severity	Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.	10 minutes
Secondary	Subjective measure of daytime sleepiness	Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.	5 minutes
Secondary	Subjective measure of physical activity	Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.	5 minutes
Secondary	Subjective measure of sedentary behaviour	Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.	5 minutes