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

NCT05961553 | Completed DMC

• 1 other identifier: 16.OBS.2020
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Pulmonary Rehabilitation; Physical Activity; Counseiling Session; Exercise

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Physical Activity Counseling + Pulmonary Rehabilitation

EXPERIMENTAL

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; Other: Pulmonary Reabilitation

Pulmonary Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Physical Activity Counseling session 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.

Physical Activity Counseling + Pulmonary Rehabilitation

Pulmonary Reabilitation OTHER

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

Physical Activity Counseling + Pulmonary Rehabilitation; Pulmonary Rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Portuguese nationality;
• Medical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022);
• Aged over 40 years.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Polytechnic Institute of Porto: lead

Study Sites (1)

Hospital Distrital da Figueira da Foz, EPE

Figueira da Foz Municipality, Coimbra District, 3094-001, Portugal

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tiago Pastilha, PT

  Escola Superior de Saúde

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 27, 2023
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)