The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with all stages of COPD
- Decision making capacity to provide informed written consent
- Ability to understand and complete the questionnaires
Exclusion Criteria:
- Exacerbation within the last four weeks
- Co-morbidities that limits the patient's physical performance more than COPD
- Any patient whom is deemed unsafe to exercise
- Patients tested on treadmill protocol 4 (i.e. Glittre testing protocol)
Sites / Locations
- LHL-klinikkene Glittre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary rehabilitation
Arm Description
Multi-disciplinary pulmonary rehabilitation
Outcomes
Primary Outcome Measures
Short physical performance battery (SPPB)
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.
Secondary Outcome Measures
Lung function
spirometry and/or whole body plethysmography
6-minute walk test (6MWT)
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)
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
Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.
Bilateral leg press 1 repetition Maximum (RM)
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)
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)
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)
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)
9- item scale that measures the impact of fatigue on a person's activities and lifestyle. Range 9-63. Higher score- greater fatigue severity.
Full Information
NCT ID
NCT02314338
First Posted
November 27, 2014
Last Updated
December 31, 2015
Sponsor
LHL Helse
Collaborators
Lovisenberg Diakonale Hospital, Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02314338
Brief Title
The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LHL Helse
Collaborators
Lovisenberg Diakonale Hospital, Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with COPD often have limitations to physical performance. There are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. Short physical performance battery is a simple test that requires little resources and can be performed both at institutions and in the homes of patients. SPPB has high predictive abilities in identifying older adults at greater risk for mortality, nursing home admission, hospitalization, and incidence of disability. The investigators would like to evaluate possible changes in the SPPB score after a 4-week rehabilitation program. The investigators would also like to look at possible relationships between the SPPB and other physical performance measures, dyspnea, anxiety, depression, fatigue, and health related quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Multi-disciplinary pulmonary rehabilitation
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
In-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team
Primary Outcome Measure Information:
Title
Short physical performance battery (SPPB)
Description
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.
Time Frame
Pre and posttest with 4 weeks in between
Secondary Outcome Measure Information:
Title
Lung function
Description
spirometry and/or whole body plethysmography
Time Frame
4 weeks
Title
6-minute walk test (6MWT)
Description
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.
Time Frame
4 weeks
Title
Borg category ratio-10 scale (Borg CR-10 scale)
Description
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.
Time Frame
4 weeks
Title
Peripheral oxygenation level
Description
Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.
Time Frame
4 weeks
Title
Bilateral leg press 1 repetition Maximum (RM)
Description
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.
Time Frame
4 weeks
Title
Modified Medical Research Council Dyspnea Scale (MMRC)
Description
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.
Time Frame
4 weeks
Title
COPD assessment test (CAT)
Description
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.
Time Frame
4 weeks
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
4 weeks
Title
Fatigue severity scale (FSS)
Description
9- item scale that measures the impact of fatigue on a person's activities and lifestyle. Range 9-63. Higher score- greater fatigue severity.
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with all stages of COPD
Decision making capacity to provide informed written consent
Ability to understand and complete the questionnaires
Exclusion Criteria:
Exacerbation within the last four weeks
Co-morbidities that limits the patient's physical performance more than COPD
Any patient whom is deemed unsafe to exercise
Patients tested on treadmill protocol 4 (i.e. Glittre testing protocol)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Edvardsen, PhD
Organizational Affiliation
LHL-klinikkene Glittre
Official's Role
Principal Investigator
Facility Information:
Facility Name
LHL-klinikkene Glittre
City
Hakadal
ZIP/Postal Code
1485
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29866200
Citation
Larsson P, Borge CR, Nygren-Bonnier M, Lerdal A, Edvardsen A. An evaluation of the short physical performance battery following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. BMC Res Notes. 2018 Jun 4;11(1):348. doi: 10.1186/s13104-018-3458-7.
Results Reference
derived
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The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)
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