The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT02314338|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : January 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Pulmonary rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Short Physical Performance Battery in COPD - Possible Impact of a Pulmonary Rehabilitation Program and Relationships to Other Physical Performance Measures, Symptoms, and Quality of Life.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Pulmonary rehabilitation
Multi-disciplinary pulmonary rehabilitation
Other: Pulmonary rehabilitation
In-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team
- Short physical performance battery (SPPB) [ Time Frame: Pre and posttest with 4 weeks in between ]SPPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance.
- Lung function [ Time Frame: 4 weeks ]spirometry and/or whole body plethysmography
- 6-minute walk test (6MWT) [ Time Frame: 4 weeks ]The 6 MWT is a timed walk test. Participants are asked to walk as far as possible, in 6 minutes. Borg CR-10 score and SpO2 will be measured before, during and/or after the 6 MWT.
- Borg category ratio-10 scale (Borg CR-10 scale) [ Time Frame: 4 weeks ]The Borg CR-10 scale is a rating scale for self-reported symptoms, in this case dyspnea. 0 represents no symptoms and 10 the worst previously experienced symptoms.
- Peripheral oxygenation level [ Time Frame: 4 weeks ]Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.
- Bilateral leg press 1 repetition Maximum (RM) [ Time Frame: 4 weeks ]1 RM bilateral leg press will be administered, after a brief warm-up, as a measure of leg strength. Starting position: Legs shoulder width apart and knee at 90 degrees angle.
- Modified Medical Research Council Dyspnea Scale (MMRC) [ Time Frame: 4 weeks ]A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with COPD. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 is a person who are to breathless to leave the house, or breathless when dressing/undressing.
- COPD assessment test (CAT) [ Time Frame: 4 weeks ]CAT is a disease-specific quality of life questionnaire. It has 8-items and a total range of 0-40, where 40 represents more severe impact of COPD on a patient's life.
- Hospital anxiety and depression scale (HADS) [ Time Frame: 4 weeks ]14-item questionnaire for screening for anxiety and depression. Each item is scored from 0-3 and each person can have a score between 0-21 for either anxiety or depression.
- Fatigue severity scale (FSS) [ Time Frame: 4 weeks ]9- item scale that measures the impact of fatigue on a person's activities and lifestyle. Range 9-63. Higher score- greater fatigue severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314338
|Hakadal, Norway, 1485|
|Principal Investigator:||Anne Edvardsen, PhD||LHL-klinikkene Glittre|