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

NCT05087017 | Unknown

• 1 other identifier: ACT.PHYS-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Fibrosis, Pulmonary

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Changes in anxiety symptoms

  3 minutes

• Changes in back pain symptoms

  2 minutes

• Changes in back pain symptoms and disability

  2 minutes

• Changes in depression symptoms

  2 minutes

Study Arms (2)

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

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.

Interventions

Intervention group OTHER

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

Intervention Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with COPD or lung fibrosis.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Fibrosis

Central Study Contacts

Juliana Macedo

CONTACT

+32470592032; juliana.ribeiro@uclouvain.be

Gregory Reychler

CONTACT

gregory.reychler@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 21, 2021
• Study Start: February 20, 2021
• Primary Completion: November 20, 2021
• Study Completion: November 1, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)