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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04162392
Other study ID # DF0084UG
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2019
Est. completion date August 2020

Study information

Verified date November 2019
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
control group
Patients receive a physiotherapy intervention but they do not have the opportunity to choose the treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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