Pulmonary Disease, Chronic ObstructiveNCT05087017
Influence of Regular Physical Activity on Sleep in Patients With COPD and Idiopathic Lung Fibrosis
An observational study of Pulmonary Disease, Chronic Obstructive and Fibrosis, Pulmonary, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Fibrosis, Pulmonary
- What is being tested?
- Intervention group
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Feb 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD or lung fibrosis.
Who may be able to join
- 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.
Who cannot join
- Regular use of Continuous Positive Airway Pressure devices (CPAP)
Trial locations and contacts
1 site in 1 country.
Gregory Reychler contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Juliana u Macedo, +32470592032, juliana.ribeiro@uclouvain.be
About this study
Official title: 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.
Read the detailed description
Patients will be selected in two ways:
- 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.
- 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.
- Being tested
- Intervention group
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Patients with medical condition to follow the rehabilitation program will be asked to answer questionnaires to assess their sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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).
Measured: 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".
Measured: 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.
Measured: 4 minutes per day
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start20 Feb 2021
- Primary completion20 Nov 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087017
- Sponsor's protocol ID
- ACT.PHYS-001
- Status last verified
- Oct 2021
- First submitted
- 8 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Regular Physical Activity on Sleep and Anxiety in Patients With Chronic Obstructive Pulmonary Disease and Idiopathic Lung Fibrosis
- ClinicalTrials.gov ID
- NCT05087017
- Acronym / sponsor ID
- ACT.PHYS-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: Intervention groupPatients 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. |
| 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD or lung fibrosis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Regular use of Continuous Positive Airway Pressure devices (CPAP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupPatients with medical condition to follow the rehabilitation program will be asked to answer questionnaires to assess their sleep quality. | Other | Intervention Group |
Primary outcome
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 - "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".
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.
4 secondary outcomes
Changes in anxiety symptoms
Time frame: 3 minutes
Changes in back pain symptoms
Time frame: 2 minutes
Changes in back pain symptoms and disability
Time frame: 2 minutes
Changes in depression symptoms
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Reychler contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Fibrosis, Pulmonary, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Macedo (+32470592032, juliana.ribeiro@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep quality - sleepiness (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.