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

Sponsor
Polytechnic Institute of Porto (Other)
Overall Status
Recruiting
CT.gov ID
NCT05961553
Collaborator
(none)
24
1
2
12
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical Activity Counseling session
  • Other: Pulmonary Reabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of an Individual Counseling Session on Physical Activity Level of Individuals With Chronic Obstructive Pulmonary Disease (COPD) - Randomized Controlled Study (RCT)
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Average Daily Steps [7 days]

    quantitative variable met through the daily average of the steps, using accelerometer data.

  2. Light Physical Activity [7 days]

    quantitative variable evaluated with the accelerometer, measured in minutes.

  3. Moderate Physical Activity [7 days]

    quantitative variable evaluated with the accelerometer, measured in minutes.

  4. Vigorous Physical Activity [7 days]

    quantitative variable evaluated with the accelerometer, measured in minutes.

  5. Sedentary Activity [7 days]

    quantitative variable evaluated with the accelerometer, measured in minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Distrital da Figueira da Foz, EPE Figueira Da Foz Coimbra Portugal 3094-001

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tiago Miguel dos Santos Pastilha, Principal Investigator, Polytechnic Institute of Porto
ClinicalTrials.gov Identifier:
NCT05961553
Other Study ID Numbers:
  • 16.OBS.2020
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tiago Miguel dos Santos Pastilha, Principal Investigator, Polytechnic Institute of Porto

Study Results

No Results Posted as of Jul 27, 2023