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

NCT ID: NCT04419792

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-09-30

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.

Conditions

Narcolepsy; Narcolepsy 1; Narcolepsy Type 1; Narcolepsy With Cataplexy; Narcolepsy Without Cataplexy; Narcolepsy and Hypersomnia; Hypersomnolence

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Narcolepsy

Assessment of physical performance variables

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. James's Hospital, Ireland

OTHER

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Ragy Tadrous

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physiotherapy, School of Medicine, Trinity College Dublin

Dublin, , Ireland

Countries

Ireland

Other Identifiers

Cross Sectional

Identifier Type: -

Identifier Source: org_study_id