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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Behavioral: Physical Activity Counseling session; Other: Pulmonary Reabilitation

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiago Pastilha, PT; Phone Number: +351968711787; Email: pastilha.tiago@gmail.com

Study Locations

• Portugal
  • Coimbra
    • Figueira Da Foz, Coimbra, Portugal, 3094-001
      • Recruiting
      • Hospital Distrital da Figueira da Foz, EPE
      • Contact: Tiago Pastilha, PT; Phone Number: +351968711787; Email: pastilha.tiago@gmail.com
      • Sub-Investigator: Rita Santos, MSc
      • Sub-Investigator: Vitória Martins, MSc
      • Sub-Investigator: Viviana Sebastião
      • Sub-Investigator: Ana Alexandrino, PhD
      • Sub-Investigator: Rui Macedo, PhD
      • Sub-Investigator: Susana Vale, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity Counseling + Pulmonary Rehabilitation; 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.	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.
Active Comparator: Pulmonary Rehabilitation; 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.	Other: Pulmonary Reabilitation; The program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Polytechnic Institute of Porto
• Investigators: Principal Investigator: Tiago Pastilha, PT, Escola Superior de Saúde; Study Director: Ana Alexandrino, PhD, Escola Superior de Saúde; Study Director: Susana Vale, PhD, Escola Superior de Educação; Study Director: Rui Macedo, PhD, Escola Superior de Saúde

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; COPD; Pulmonary Rehabilitation; Counseiling Session
• Other Study ID Numbers: 16.OBS.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No