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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02493790
Other study ID # 5S-DYSCO
Secondary ID
Status Completed
Phase N/A
First received June 30, 2015
Last updated December 19, 2016
Start date October 2014
Est. completion date August 2016

Study information

Verified date December 2016
Source 5 Santé
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 2016
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Cognitive and motor performances


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
5 Santé Groupe 5 Santé

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months No
Primary 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 3 months No
Secondary 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) 3 months No
Secondary 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 3 months No
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