Chronic Obstructive Pulmonary DiseaseDysCoNCT02493790
Cognitive Dysfunction in COPD Patients : Role in the Performance of Cognitive-motor Dual Task Situation?
An observational study of Chronic Obstructive Pulmonary Disease, run by 5 Santé.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point characterized by multiple systemic effects as cognitive dysfunction. This one seems to have an impact in activity daily living, considered mainly as a cognitive-motor dual task situations. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Cognitive and motor performances
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Aug 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients, entered in a rehabilitation program in Clinique du Souffle were included
Who may be able to join
- Male or female about 40 to 80 years old
- COPD patient (Tiffeneau <70%); stage moderate to severe (Stage 2,3 and 4) with or without oxygen therapy (>15h/day)
- Written and informed consent of the subject
- Authorization to physical activity referring doctor in the clinic
- Comorbidities no dominating
Who cannot join
- Subject with neurological pathology, cognitive or psychiatric
- Subject with pain and / or plantar injuries
- Subject has a prosthetic knee and / or hip.
- Subject requiring walking aid (cane, walker, etc.)
About this study
Official title: Impact of Cognitive Dysfunction in Chronic Obstructive Pulmonary Disease on Performance in Cognitive-motor Dual Task Situation
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point characterized by multiple systemic effects as cognitive dysfunction. This one seems to have an impact in activity daily living, considered mainly as a cognitive-motor dual task situations. Yet to date, no study has specifically focused in the cognitive-motor performance in patients with COPD or on the effects during a rehabilitation program. The main objective of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing performance between COPD patients and healthy subjects in a single and dual task cognitive-motor situation. The secondary objective was to assess the impact of a rehabilitation program on these performances.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Cognitive and motor performances
- Keywords
- cognitive dysfunction, Activity of Daily Living, interference, rehabilitation, cognitive-motor dual task
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and motor performancesOther
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Cognitive and motor performances were measured in a single and dual task situations. Receives: Other: Cognitive and motor performances | |
| COPD patients | Cognitive and motor performances were measured in a single and dual task situations, before rehabilitation, and compared to those of healthy subjects. Then, Chronic Obstructive Pulmonary Disease patients were re-evaluated after rehabilitation. Receives: Other: Cognitive and motor performances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of Cognitive performances in a single and dual task situations
Cognitive performance were determined by error count and number of substraction during a counting task.
Measured: 3 months
Variability of motor performances in a single and dual task situations
Motor performance were determined by variability of length and surface of postural condition and by step variability in locomotion condition
Measured: 3 months
Secondary outcomes (2)
Effect of rehabilitation program on Cognitive performances in a single and dual task
Comparison before and after rehabilitation program of counting task (number of substraction and error count)
Measured: 3 months
Effect of rehabilitation program on motor performances in a single and dual task
Comparison before and after rehabilitation program of variability of length and surface of postural condition and step variability in locomotion condition
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe 5 Santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493790
- Sponsor's protocol ID
- 5S-DYSCO
- Acronym
- DysCo
- Status last verified
- Dec 2016
- First submitted
- 30 Jun 2015
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cognitive Dysfunction in Chronic Obstructive Pulmonary Disease on Performance in Cognitive-motor Dual Task Situation
- ClinicalTrials.gov ID
- NCT02493790
- Acronym / sponsor ID
- DysCo / 5S-DYSCO
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- cognitive dysfunction, Activity of Daily Living, interference, rehabilitation, cognitive-motor dual task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Collaborators
- Groupe 5 Santé
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point characterized by multiple systemic effects as cognitive dysfunction. This one seems to have an impact in activity daily living, considered mainly as a cognitive-motor dual task situations. Yet to date, no study has specifically focused in the cognitive-motor performance in patients with COPD or on the effects during a rehabilitation program. The main objective of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing performance between COPD patients and healthy subjects in a single and dual task cognitive-motor situation. The secondary objective was to assess the impact of a rehabilitation program on these performances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Other: Cognitive and motor performancesCognitive and motor performances were measured in a single and dual task situations. |
| COPD patients | – | Other: Cognitive and motor performancesCognitive and motor performances were measured in a single and dual task situations, before rehabilitation, and compared to those of healthy subjects. Then, Chronic Obstructive Pulmonary Disease patients were re-evaluated after rehabilitation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients, entered in a rehabilitation program in Clinique du Souffle were included
Key inclusion criteria (5 listed)
- Male or female about 40 to 80 years old
- COPD patient (Tiffeneau <70%); stage moderate to severe (Stage 2,3 and 4) with or without oxygen therapy (>15h/day)
- Written and informed consent of the subject
- Authorization to physical activity referring doctor in the clinic
- Comorbidities no dominating
Key exclusion criteria (4 listed)
- Subject with neurological pathology, cognitive or psychiatric
- Subject with pain and / or plantar injuries
- Subject has a prosthetic knee and / or hip.
- Subject requiring walking aid (cane, walker, etc.)
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 |
|---|---|---|
| Cognitive and motor performances | Other | COPD patients, Volunteers |
Primary outcome
Variability of Cognitive performances in a single and dual task situations
Time frame: 3 months
Cognitive performance were determined by error count and number of substraction during a counting task.
Variability of motor performances in a single and dual task situations
Time frame: 3 months
Motor performance were determined by variability of length and surface of postural condition and by step variability in locomotion condition
2 secondary outcomes
Effect of rehabilitation program on Cognitive performances in a single and dual task
Time frame: 3 months
Effect of rehabilitation program on motor performances in a single and dual task
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by 5 Santé.
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 4 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: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of Cognitive performances in a single and dual task situations (time frame: 3 months). The study lists 2 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 20 Dec 2016.