Effect on the incidence of exacerbations of a programme of physical activity encouragement using pedometers in patients with chronic obstructive pulmonary disease

Plain English summary of protocol

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is the most common long-term respiratory illness in adults and is a major cause of death and disability. In Chile, COPD is the leading respiratory disease in terms of its impact on health. One of the national health goals for this decade is to reduce the illness and deaths caused by COPD.

COPD causes long-term blockage of airflow, leading to breathing difficulties, especially during physical activity. This condition lowers a person's ability to exercise, causes them to be less active, and worsens their overall health and quality of life. Patients with COPD experience worsening symptoms, called acute exacerbations, about twice a year on average. These exacerbations are marked by a sudden increase in breathing difficulty, coughing, and mucus production, often requiring urgent medical visits and sometimes hospital stays. About 40% of patients who have an exacerbation need to be hospitalized, which is costly and associated with a lower chance of survival.

Research shows that physical activity is crucial for people with COPD. More active patients experience fewer symptoms, enjoy a better quality of life, and, regardless of lung function, sex, or other illnesses, have fewer hospitalizations and lower mortality rates than those who are less active.

Our team conducted a 3-month clinical trial where patients with COPD used step counters to encourage physical activity.

Who can participate?
Patients aged 40 years and older, with COPD.

What does the study involve?
Participants are randomly assigned to the experimental or the control group.
Experimental Group: Patients use step counters and logs, with goals to increase steps based on baseline and monthly check-ups.
Control Group: Patients attend monthly physical therapist visits, recording symptoms and treatments in a logbook reviewed only by the physician.
The study involves attending hospitals regularly once a month until the follow-up is completed. The visits are brief, about 20 to 30 minutes, and they are helped with the cost of their travel. For the evaluations, they should allow more time (approximately 2 hours).

What are the possible benefits and risks of participating?
This study does not contemplate a direct benefit for patients except that all patients who complete the study are given a step counter. For patients in the experimental group, the step counter is given to them at the beginning of the follow-up; for patients in the control group, it is given to them at the end of their follow-up after the last evaluation.
Since the intervention consists only of walking supported by the step counter, it does not imply any risks for patients. Nor do the evaluations include any significant risk for patients.

Where is the study run from?
Agencia Nacional de Investigación y Desarrollo (Chile)

When is the study starting and how long is it expected to run for?
March 2019 to December 2023

Who is funding the study?
Agencia Nacional de Investigación y Desarrollo (Chile)

Who is the main contact?
Dr Laura Mendoza, lmendoza@hcuch.cl

Contact information

Dr Laura Mendoza
Public, Scientific, Principal Investigator

Dr. Carlos Lorca 999 Independencia
Santiago
8380000
Chile

ORCID ID	0000-0001-5426-0439
Phone	+56 229788409
Email	lmendoza@hcuch.cl

Study information

Eligibility

Locations

Countries of recruitment

• Chile

Study participating centres

Sponsor information

Agencia Nacional de Investigación y Desarrollo
Government

Moneda 1375
Santiago
8340755
Chile

Phone	+56 223654400
Email	oficinadepartes@anid.cl
Website	https://www.anid.cl/
"ROR"	https://ror.org/02ap3w078

Funders

Funder type

Government

Results and Publications

Editorial Notes

01/07/2024: Trial's existence confirmed by Comité Ético Cientifico o de Investigación del Hospital Clínico de la Universidad de Chile