NCT04890080

Brief Summary

110 COPD patients who were participated in the PR program were included in the study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Status
completed

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

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

May 12, 2021

Last Update Submit

May 12, 2021

Conditions

Pulmonary RehabilitationExerciseCOPDResting Heart Rate

Keywords

resting heart rateCOPDexercisepulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Resting Heart Rate

    number of beats per minute

    1 minute

Secondary Outcomes (4)

  • Functional Capacity

    Change from baseline six minute walk distance at 8 week

  • Dyspnea Assessment

    Change from baseline dyspnea at 8 week

  • Quality of Life Assessment

    Change from baseline dyspnea at 8 week

  • Anxiety and Depression

    Change from baseline dyspnea at 8 week

Study Arms (1)

PR Group

EXPERIMENTAL

Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program

Other: Pulmonary Rehabilitation

Interventions

Pulmonary RehabilitationOTHER

Exercise training consisted of supervised breathing, aerobic, strengthening and stretching exercises for 8 weeks, 2 days a week. Breathing exercises included pursed lip, diaphragmatic, thoracic expansion and basal expansion exercises. Strength training included the lower and upper extremities, and it was performed 8-10 repetitions, either against gravity or using free weight, according to patient tolerance.

PR Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program

You may not qualify if:

  • With cardiovascular disease
  • With additional diseases such as diabetes
  • Receiving medical treatment that affects the autonomic nervous system
  • Patients receiving long-term oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 18, 2021

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

April 1, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share