NCT02517411

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by incompletely reversible airflow obstruction. It is projected to be the fifth leading burden of disease worldwide by the year 2020. Pulmonary dysfunction reduces exercise capacity in COPD patients, and it has been previously shown that COPD patients suffer deterioration in their quality of life. The objective of this study is to examine the effects of a physical therapy intervention in stable patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

August 2, 2015

Last Update Submit

October 30, 2016

Conditions

COPD

Keywords

COPDphysiotherapyStable disease

Outcome Measures

Primary Outcomes (2)

  • Changes in Muscle strength

    Quadriceps strength will be assessed with a portable dynamometer.

    Baseline, 8 weeks

  • Changes in Exercise capacity

    Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.

    Baseline, 8 weeks

Secondary Outcomes (5)

  • Changes in Respiratory function

    Baseline, 8 weeks

  • Changes in Dyspnea perception

    Baseline, 8 weeks

  • Changes in Quality of life

    Baseline, 8 weeks

  • Changes in Fatigue

    Baseline, 8 weeks

  • Impact of COPD

    Baseline, 8 weeks

Other Outcomes (4)

  • Quality of life related to respiratory symptoms

    Baseline

  • Peripheral vascular status

    Baseline

  • Physical activity

    Baseline

  • +1 more other outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.

Other: Physiotherapy added to standard care

Control group

OTHER

COPD patients with stable disease will be recruited and they will receive standard care.

Other: Standard care

Interventions

Standard careOTHER

The standard care of stable COPD is based on long-acting bronchodilators (LABD).

Also known as: standard treatment
Control group
Physiotherapy added to standard careOTHER

The treatment will be based on domiciliary physiotherapy program during 8 weeks, twice a week added to standard care. The duration of the sessions will be 45-60 minutes. The physiotherapy treatment includes: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband. This will be a home-based program supervised by a physiotherapist.

Also known as: Physiotherapy, Home-based program, Domiciliary physiotherapy
Experimental group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD diagnosis
  • No contraindication of physiotherapy.
  • Signed written consent.

You may not qualify if:

  • Acute exacerbation in the previous month
  • Contraindications of physiotherapy.
  • Neurological, orthopedic or heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of CarePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationTherapeuticsRehabilitation

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 2, 2015

First Posted

August 7, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

ES(1)