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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
Sponsor:
Collaborators:
Lovisenberg Diakonale Hospital
Karolinska Institutet
Information provided by (Responsible Party):
LHL Helse

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Pulmonary rehabilitation Not Applicable

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Lung function [ Time Frame: 4 weeks ]
    spirometry and/or whole body plethysmography

  2. 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.

  3. 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.

  4. Peripheral oxygenation level [ Time Frame: 4 weeks ]
    Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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Norway
LHL-klinikkene Glittre
Hakadal, Norway, 1485
Sponsors and Collaborators
LHL Helse
Lovisenberg Diakonale Hospital
Karolinska Institutet
Investigators
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Principal Investigator: Anne Edvardsen, PhD LHL-klinikkene Glittre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LHL Helse
ClinicalTrials.gov Identifier: NCT02314338     History of Changes
Other Study ID Numbers: REK2014/1499
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: September 2015

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases