The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Pulmonary rehabilitation

• Registration Number: NCT02314338
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-11
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-31
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary rehabilitation	Pulmonary rehabilitation	Multi-disciplinary pulmonary rehabilitation

Primary Outcome Measures

Name	Time	Method
Short physical performance battery (SPPB)	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

Name	Time	Method
COPD assessment test (CAT)	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.
Fatigue severity scale (FSS)	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.
6-minute walk test (6MWT)	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.
Peripheral oxygenation level	4 weeks	Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.
Hospital anxiety and depression scale (HADS)	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.
Lung function	4 weeks	spirometry and/or whole body plethysmography
Borg category ratio-10 scale (Borg CR-10 scale)	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.
Bilateral leg press 1 repetition Maximum (RM)	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)	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.

Trial Locations

Locations (1)

LHL-klinikkene Glittre; 🇳🇴 Hakadal, Norway