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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive; Fibrosis, Pulmonary
• Intervention / Treatment: Other: Intervention group

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Juliana Macedo; Phone Number: +32470592032; Email: juliana.ribeiro@uclouvain.be
• Study Contact Backup: Name: Gregory Reychler; Email: gregory.reychler@uclouvain.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Juliana u Macedo; Phone Number: +32470592032; Email: juliana.ribeiro@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with COPD or lung fibrosis.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Group; Patients with COPD or Lung Fibrosis following rehabilitation program will be invited to participate and answer the questionnaires in the beginning and after eight weeks of rehabilitation.	Other: Intervention group; Patients with medical condition to follow the rehabilitation program will be asked to answer questionnaires to assess their sleep quality.
Control group; Patients with COPD or Lung Fibrosis who do not do any regular activity will be invited to participated and answer the questionnaires just once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sleep quality - sleepiness	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".	2 minutes
Changes in sleep quality - insomnia	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).	2 minutes
Changes in sleep quality - "Morningness" or "eveningness" types	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".	2 minutes
Changes in sleep quality - Sleep Agenda	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.	4 minutes per day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety symptoms	Nijmegen 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.	3 minutes
Changes in back pain symptoms	Back 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.	2 minutes
Changes in back pain symptoms and disability	Back 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.	2 minutes
Changes in depression symptoms	Depression 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.	2 minutes

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Anticipated): November 20, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Fibrosis; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis
• Other Study ID Numbers: ACT.PHYS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No