NCT04117399

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals. Risk of falls is multi-factorial and impaired balance has been shown to contribute. The investigators aimed to demonstrate that, IMT performed during a PRP may improve Postural control in COPD patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

September 28, 2019

Last Update Submit

October 3, 2019

Conditions

Keywords

COPDIMTCoP MLCoP APPosture

Outcome Measures

Primary Outcomes (1)

  • Balance outcomes

    Balance were measured by stabilometry to evaluate postural control in COPD patients. Two principals variabels were evaluated: the center of pressure in the mediolateral direction (CoP ML) ; the center of presure in anteroposterior direction (CoP AP).

    Basline, After 2 months

Study Arms (2)

IMT group

EXPERIMENTAL

Inspiratory muscle training + aerobic exercice

Other: Pulmonary rehabilitation

Control group

ACTIVE COMPARATOR

aerobic exercice

Other: Pulmonary rehabilitation

Interventions

The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise group received only aerobic exercise.

Control groupIMT group

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Were COPD diagnosed by pulmonary function testing
  • Clinically stable
  • Abscence of other obstructive diseases
  • Signed written consert

You may not qualify if:

  • Were previous pneumonectomy or lobectomy in the past 6 months
  • Spontaneous risk of pneumothorax or rib fracture
  • Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
  • Lower limb injury
  • Neurological injury or disease
  • The absence of written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilel TOUNSI

Sousse, 4002, Tunisia

Location

Related Publications (2)

  • Smith MD, Chang AT, Seale HE, Walsh JR, Hodges PW. Balance is impaired in people with chronic obstructive pulmonary disease. Gait Posture. 2010 Apr;31(4):456-60. doi: 10.1016/j.gaitpost.2010.01.022. Epub 2010 Mar 4.

    PMID: 20206529BACKGROUND
  • Janssens L, Brumagne S, McConnell AK, Claeys K, Pijnenburg M, Burtin C, Janssens W, Decramer M, Troosters T. Proprioceptive changes impair balance control in individuals with chronic obstructive pulmonary disease. PLoS One. 2013;8(3):e57949. doi: 10.1371/journal.pone.0057949. Epub 2013 Mar 1.

    PMID: 23469255BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2019

First Posted

October 7, 2019

Study Start

February 1, 2019

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

October 7, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations