Physical Activity Barriers in AECOPD

Physical Activity Barriers in Acute Exacerbated COPD

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Patients require good communication with the physician to improve control illness. Shared decision making is a good option to improve physical activity barriers in acute exacerbated COPD patients during the hospitalization period.

Study Overview

• Status: Unknown
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: shared decision making; Other: control group

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria were COPD patients hospitalized due to acute exacerbation

Exclusion Criteria:

• Exclusion criteria were the inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: control group; Patients receive a physiotherapy intervention but they do not have the opportunity to choose the treatment
Experimental: Experimental group	Other: shared decision making; Patients can choose the intervention that they want. There are different physiotherapy interventions were the patients have to do physical activity during the hospital stay. The physiotherapist explains the advantages and disadvantages of each treatment before they choose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life: EQ-5D	European Quality of Life questionnaire consists of the EQ-5D visual analog scale and the EQ-5D index. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health). The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).	Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
Functional capacity	The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.	Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
Barriers to Being Active Quiz	The Barriers to Being Active Quiz is a 21-item scale that provides a measure of 7 self-reported barriers to being physically active.This instrument uses a 4-point Likert scale for individuals to identify if they would say or think any of the statements would be true for them, with 0 being very unlikely to 3 being very likely. Per instrument instructions, each barrier has 3 items that are summed for scoring, with a range of 0 to 9 for each.	Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DF0084UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No