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Clinical Trials/NCT05087017
NCT05087017
Unknown
Not Applicable

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country150 target enrollmentFebruary 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Enrollment
150
Locations
1
Primary Endpoint
Changes in sleep quality - sleepiness
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2021
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Changes in sleep quality - sleepiness

Time Frame: 2 minutes

Sleep 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 - insomnia

Time Frame: 2 minutes

Sleep 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 - Sleep Agenda

Time Frame: 4 minutes per day

Sleep 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 - "Morningness" or "eveningness" types

Time Frame: 2 minutes

Sleep 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 Outcomes

  • Changes in back pain symptoms and disability(2 minutes)
  • Changes in depression symptoms(2 minutes)
  • Changes in back pain symptoms(2 minutes)
  • Changes in anxiety symptoms(3 minutes)

Study Sites (1)

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