Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
St. James's Hospital, Ireland
Information provided by (Responsible Party):
Ragy Tadrous, University of Dublin, Trinity College

Tracking Information
First Submitted Date May 12, 2020
First Posted Date June 5, 2020
Last Update Posted Date June 5, 2020
Actual Study Start Date October 15, 2019
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2020)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 4, 2020)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Official Title 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The following eligibility criteria: Aged 18 to 65 years, diagnosis of type 1 or type 2 narcolepsy based on the International Classification of Sleep Disorders third edition criteria for at least six months, eligibility screened by their treating clinician, and able to understand English and follow simple instruction to enable completion of assessments. Additionally, participants will be required to provide signed and informed consent to participate in the study, and for processing of their data to be eligible for participation. Individuals with sleep disorders other than narcolepsy, contraindications to moderate-intensity exercise, confirmed pregnancy or significant psychiatric illness or cognitive impairment will be excluded from participating in the study.
Condition
  • Narcolepsy
  • Narcolepsy 1
  • Narcolepsy Type 1
  • Narcolepsy With Cataplexy
  • Narcolepsy Without Cataplexy
  • Narcolepsy and Hypersomnia
  • Hypersomnolence
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

Study Groups/Cohorts Narcolepsy
Intervention: Other: Assessment of physical performance variables
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: June 4, 2020)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04419792
Other Study ID Numbers Cross Sectional
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: In keeping with the research policy of Trinity College Dublin, relevant and anonymised data and materials will be made available through Trinity College's Access to Research Archive (TARA) data depository.
Supporting Materials: Study Protocol
Responsible Party Ragy Tadrous, University of Dublin, Trinity College
Study Sponsor University of Dublin, Trinity College
Collaborators St. James's Hospital, Ireland
Investigators Not Provided
PRS Account University of Dublin, Trinity College
Verification Date June 2020