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Influence of Regular Physical Activity on Sleep in Patients With COPD and Idiopathic Lung Fibrosis

Influence of Regular Physical Activity on Sleep and Anxiety in Patients With Chronic Obstructive Pulmonary Disease and Idiopathic Lung Fibrosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05087017
Enrollment
150
Registered
2021-10-21
Start date
2021-02-20
Completion date
2022-11-01
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis, Pulmonary, Pulmonary Disease, Chronic Obstructive

Brief summary

The study looked at whether regular physical activity can influence sleep duration, sleep quality and/or anxiety in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF). The link between exercise and sleep has already been observed in the literature, but the impact of exercise on sleep is poorly understood. The question is how important is the influence of regular physical activity on sleep, anxiety and depression in patients with COPD or IPF.

Detailed description

Patients will be selected in two ways: 1. Intervention group: patients with COPD or idiopathic fibrosis following rehabilitation program in our center, who meet the inclusion criteria will be invited to participate in the survey and answer the questionnaires during the first week and again eight weeks after the start of the rehabilitation program. 2. Control group: patients with COPD or idiopathic fibrosis who do not perform any regular physical activity will be invited to participate in the survey and answer the questionnaires. The questionnaires are validated and the time allowed for completion is 45 minutes. The questionnaires will assess sleep quality, anxiety and symptoms of depression.

Interventions

OTHERIntervention group

Patients with medical condition to follow the rehabilitation program will be asked to answer questionnaires to assess their sleep quality.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients with COPD. * Patients with Idiopathic Pulmonary Fibrosis. * Patients who can read and write in French. * Patients who agree to participate in research and sign the informed consent form. * Patients who participated of our rehabilitation program or Patients who do not do any regular exercise activity.

Exclusion criteria

* Regular use of Continuous Positive Airway Pressure devices (CPAP)

Design outcomes

Primary

MeasureTime frameDescription
Changes in sleep quality - Sleep Agenda4 minutes per daySleep quality will be assessed by the questionnaire Sleep Agenda. The sleep agenda is a subjective method of sleep evaluation which demand the patient to fill the agenda at two times of the day: at 9 in the morning to describe what happened at night and 9 in the evening to report what happened in the day for a minimum of three weeks. The patient need to specify the quality of his night, if it was very good, good, average, bad and very bad and specify, also, if he took any medications or if something happened may have interfered with his sleep.
Changes in sleep quality - sleepiness2 minutesSleep quality will be assessed by the questionnaire Epworth Sleepiness Scale. A score between 0-5 indicates lower normal daytime sleeping; between 6-10 higher normal daytime sleepiness; 11-12 mil excessive daytime sleepiness; 13-15 moderate excessive daytime sleepiness and 16-24 severe excessive daytime sleepiness.
Changes in sleep quality - insomnia2 minutesSleep quality will be assessed by the questionnaire Insomnia Severity Index . A scale is used to rank each item, where 0 means no problem, 1 - mild problem, 2 - moderate 3 - severe and 4 very severe problem. The total score is interpreted as absence of insomnia (0-7); sub-threshold insomnia (8-14); Moderate insomnia (15-21); and severe insomnia (22-28).
Changes in sleep quality - Morningness or eveningness types2 minutesSleep quality will be assessed by the questionnaire Morningness - Eveningness Questionnaire . Scores between 42 and 58 indicate neural types, scores of 59 and above indicate morning types and scores of 41 and below indicates evening types.

Secondary

MeasureTime frameDescription
Changes in anxiety symptoms3 minutesNijmegen Questionnaire is a valid questionnaire to detect patients who have hyperventilation symptoms which the complaints may not be fully due to physiological abnormality, that is, it reflects a subjective aspect of dysfunctional breathing reflecting anxiety symptoms. Scores \> 23 is indicative of dysfunctional breathing.
Changes in back pain symptoms2 minutesBack pain will be assessed by the STarT Back Screening Tool. It is a quick-to-use self-administered questionnaire (9 items) that classifies patients with low, medium or high risk of low back pain. The score higher than 5 represents high risk of low back pain.
Changes in back pain symptoms and disability2 minutesBack pain will be assessed by Oswestry Disability Index. It gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. The score goes to 0 to 100 describing the level of disability. The higher the score, the greater the severity of disability.
Changes in depression symptoms2 minutesDepression symptoms will be assessed by Beck Depression Inventory . It is composed of 21 items of symptoms and attitudes depressives, each category describes a specific behavioral manifestation of depression. The score goes from 1 to 40 describing the level of depression. The higher the score, the greater the severity of depression.

Countries

Belgium

Contacts

Primary ContactJuliana Macedo
juliana.ribeiro@uclouvain.be+32470592032
Backup ContactGregory Reychler
gregory.reychler@uclouvain.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026