Narcolepsy Clinical Trial
Official title:
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Verified date | June 2020 |
Source | University of Dublin, Trinity College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Suspended |
Enrollment | 70 |
Est. completion date | September 30, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Ireland | Department of Physiotherapy, School of Medicine, Trinity College Dublin | Dublin |
Lead Sponsor | Collaborator |
---|---|
University of Dublin, Trinity College | St. James's Hospital, Ireland |
Ireland,
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 |
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