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

NCT ID: NCT05961553

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-12-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pulmonary Reabilitation

Intervention Type: OTHER

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

Physical Activity Counseling session

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Pulmonary Reabilitation

Intervention Type: OTHER

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

Interventions

Pulmonary Reabilitation

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

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polytechnic Institute of Porto

OTHER

Sponsor Role: lead

Responsible Party

Tiago Miguel dos Santos Pastilha

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiago Pastilha, PT

Role: PRINCIPAL_INVESTIGATOR

Escola Superior de Saúde

Ana Alexandrino, PhD

Role: STUDY_DIRECTOR

Escola Superior de Saúde

Susana Vale, PhD

Role: STUDY_DIRECTOR

Escola Superior de Educação

Rui Macedo, PhD

Role: STUDY_DIRECTOR

Escola Superior de Saúde

Locations

Hospital Distrital da Figueira da Foz, EPE

Figueira da Foz Municipality, Coimbra District, Portugal

Countries

Portugal

Other Identifiers

16.OBS.2020

Identifier Type: -

Identifier Source: org_study_id