Effect of an Individual Counseling Session on Physical Activity Level of Individuals With COPD

COPD Clinical Trial

Official title:

Effect of an Individual Counseling Session on Physical Activity Level of Individuals With Chronic Obstructive Pulmonary Disease (COPD) - Randomized Controlled Study (RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961553
• Other study ID #: 16.OBS.2020
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Polytechnic Institute of Porto
• Contact: Tiago Pastilha, PT
• Phone: +351968711787
• Email: pastilha.tiago[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. The main question[s] it aims to answer are:

• Does a counseling session improve the level of physical activity and motivation to practice physical exercise in individuals with COPD?

Participants will perform a respiratory rehabilitation program (Control Group, CG) and a respiratory rehabilitation program and the counseling session (Experimental Group, EG).

Researchers will compare EG to CG to see if there is any difference in physical activity level and motivation to exercise between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Portuguese nationality;

• Medical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022);

• Aged over 40 years.

Exclusion Criteria:

• underwent recent orthopedic surgeries (<3 months);

• Pregnant;

• Terminal illness diagnosis (life expectancy of less than 6 months);

• High cardiovascular risk classification for the practice of physical activity according to American College of Sports Medicine (ACSM 2018).

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Physical Activity Counseling session
The counseling session on physical activity was carried out individually, six weeks after starting the respiratory rehabilitation program, with an average duration of 30 minutes, based on the guidelines of the Living Well with COPD program. The main objective of the session was: to help the participant and family members to increase physical activity levels and their integration in the long term and as secondary objectives; reinforce the importance and benefits of physical activity in the management of the health condition/symptoms; plan daily/weekly moments of physical activity; define daily goals (physical activity time/sitting time) attainable for each participant; integrate family members/companions into the user's physical activity plan; clarify doubts of the user/relative about the theme.

Other:
• Pulmonary Reabilitation
The program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session.

Locations

Country	Name	City	State
Portugal	Hospital Distrital da Figueira da Foz, EPE	Figueira Da Foz	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Polytechnic Institute of Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daily Steps	quantitative variable met through the daily average of the steps, using accelerometer data.	7 days
Primary	Light Physical Activity	quantitative variable evaluated with the accelerometer, measured in minutes.	7 days
Primary	Moderate Physical Activity	quantitative variable evaluated with the accelerometer, measured in minutes.	7 days
Primary	Vigorous Physical Activity	quantitative variable evaluated with the accelerometer, measured in minutes.	7 days
Primary	Sedentary Activity	quantitative variable evaluated with the accelerometer, measured in minutes.	7 days