Micro-doses of Physical Activity for COPD

NCT05553223 | Recruiting

• 1 other identifier: H18-01575
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that makes it hard for people to breath. Those with COPD spend considerably more time sitting and lying and less time performing physical activity than healthy individuals. Those who are the most sedentary have a greater risk of heart and blood vessel disease, which may lead to an early death. This project will investigate the effect of sitting still for 3 hours on blood vessel health in individuals with COPD. It will also investigate whether breaking up the amount of time patients sit with regular short bouts of walking (5 minutes each hour) at a comfortable pace chosen by the patient can have a positive effect on maintaining the health of their blood vessels. It is hypothesized that blood vessel health will be worse after 3 hours of sitting compared to when the sitting is broken up by short bouts of walking.

Conditions

Chronic Obstructive Pulmonary Disease; Endothelial Dysfunction; Vascular Stiffness; Hypertension; Cardiovascular Diseases

Keywords

Microdoses of Physical Activity; Flow Mediated Dilation; Reactive Hyperemia

Outcome Measures

Primary Outcomes (1)

• Change in superficial femoral artery endothelial function

  The change in endothelial function (measured by the flow-mediated dilation response to reactive hyperaemia of the superficial femoral artery using ultrasound) from baseline to 3-hours of prolonged sitting in the control condition compared to performing 3-hours of sitting broken up by micro-doses of physical activity.

  Within 3 hours of sitting (Day1) or within 3 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.

Secondary Outcomes (2)

• Difference in 24-hour ambulatory blood pressure between the two conditions

  Within 24 hours of sitting (Day 1) or within 24 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.

• Change in superficial femoral artery blood flow patterns

  Within 3 hours of sitting (Day1) or within 3 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.

Other Outcomes (4)

• Time course of change in endothelial function of the superficial femoral artery

  Within 1 hour, 2 hours and 3 hours of sitting (Day1) or within 1 hour, 2 hours and 3 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.

• Change in central arterial stiffness

  Within 3 hours of sitting (Day1) or within 3 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.

• Time course of change in superficial femoral artery blood flow patterns

  Within 30, 60, 90, 120, 150 and 180 minutes of sitting (Day1) or within 30, 60, 90, 120, 150 and 180 minutes of sitting broken up by micro-doses of physical activity (Day 2). Days performed in a randomized order.

Study Arms (2)

Microdoses of Activity

EXPERIMENTAL

5-min bouts of walking will break up 3 hours of sitting at minutes 30, 90 and 150.

Behavioral: Microdoses of activity

Control

NO INTERVENTION

Prolonged sitting (3 hours)

Interventions

Microdoses of activity BEHAVIORAL

Short bouts of low-intensity exercise (walking) will be used to break up prolonged sitting.

Microdoses of Activity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking (\>6 months) patients with stable moderate-to-severe COPD (post bronchodilator forced expired volume in 1 sec/forced vital capacity\<0.7 and \<lower limit of normal, 30%\<Forced Expired Volume in 1 sec\<80% predicted and exacerbation free for \>6 weeks) will be recruited for the study.

You may not qualify if:

• performing structured exercise training (or pulmonary rehabilitation)
• have a history of deep vein thrombosis
• are on anticoagulant medication
• have advanced cardiac or cerebrovascular disease (i.e. heart failure, previous stroke or myocardial infarction)
• have diabetes
• have musculoskeletal contraindications that limit their ability to perform physical activity
• vascular ultrasound measurements cannot be obtained.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V2L2, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension; Cardiovascular Diseases; Hyperemia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Neil Eves, PhD

CONTACT

250-807-9676; neil.eves@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator who will analyze the primary outcome data will be blinded to the participant and condition.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will be performed using a prospective randomized crossover design with subjects acting as their own control.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: September 23, 2022
• Study Start: October 12, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)