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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Behavioral: Physical Activity Counseling session; Other: Pulmonary Reabilitation

• Registration Number: NCT05961553
• Lead Sponsor: Polytechnic Institute of Porto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-16
• Study First Posted: 2023-07-27
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Counseling + Pulmonary Rehabilitation	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.
Pulmonary Rehabilitation	Pulmonary Reabilitation	The program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session, which included: monitoring of vital signs, peripheral oxygen saturation (SpO2), subjective perception of exertion (RPE), dyspnea and body mass; warm-up phase (10min), with ventilatory control and low-intensity upper and lower limb exercises; continuous aerobic training phase, performed on a treadmill, static cycle ergometer and/or arm ergometer (30-45min), at 60-80% of the maximum Cardiopulmonary Exercise Test load; strength training phase, with free weights, machines (10-20min), at 50-80% of the Maximum Repetition (RM), (8-12 repetitions), 1-2 sets, 8-10 exercises ( upper limbs, trunk and lower limbs); cooling phase (5-10min), with 5 to 8 relaxation, stretching and ventilatory control exercises. The progression of training loads is carried out according to RPE and dyspnea, safeguarding SpO2 values above 88-90% and Heart Rate below the maximum defined for training.
Physical Activity Counseling + Pulmonary Rehabilitation	Pulmonary Reabilitation	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.

Primary Outcome Measures

Name	Time	Method
Moderate Physical Activity	7 days	quantitative variable evaluated with the accelerometer, measured in minutes.
Average Daily Steps	7 days	quantitative variable met through the daily average of the steps, using accelerometer data.
Light Physical Activity	7 days	quantitative variable evaluated with the accelerometer, measured in minutes.
Vigorous Physical Activity	7 days	quantitative variable evaluated with the accelerometer, measured in minutes.
Sedentary Activity	7 days	quantitative variable evaluated with the accelerometer, measured in minutes.

Trial Locations

Locations (1)

Hospital Distrital da Figueira da Foz, EPE; 🇵🇹 Figueira Da Foz, Coimbra, Portugal