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

Suspended

• Conditions: Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy; Narcolepsy and Hypersomnia; Narcolepsy; Narcolepsy 1; Narcolepsy Type 1; Hypersomnolence
• Interventions: Other: Assessment of physical performance variables

• Registration Number: NCT04419792
• Lead Sponsor: University of Dublin, Trinity College

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-15
• Study First Submitted: 2020-05-12
• Primary Completion: 2020-05-31
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-05
• Last Update Posted: 2020-06-05
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Narcolepsy	Assessment of physical performance variables	-

Primary Outcome Measures

Name	Time	Method
Measurement of upper limb endurance	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 oxygen uptake during cardiopulmonary exercise testing (% predicted)	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 lower limb endurance	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.	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 grip strength	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 physical activity	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.

Secondary Outcome Measures

Name	Time	Method
Subjective measure of Health-Related Quality of Life	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)	10 minutes	Health-related quality of life will be subjectively assessed using the Functional Outcomes of Sleep Questionnaire questionnaires
Subjective measure of daytime sleepiness	5 minutes	Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.
Subjective measure of physical activity	5 minutes	Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.
Subjective measure of sedentary behaviour	5 minutes	Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.
Subjective measure of symptom severity	10 minutes	Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.

Trial Locations

Locations (1)

Department of Physiotherapy, School of Medicine, Trinity College Dublin; 🇮🇪 Dublin, Ireland