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

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314338
• Other study ID #: REK2014/1499
• Status: Completed
• Phase: N/A
• First received: November 27, 2014
• Last updated: December 31, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: LHL Helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Norway	LHL-klinikkene Glittre	Hakadal

Sponsors (3)

Lead Sponsor	Collaborator
LHL Helse	Karolinska Institutet, Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre and posttest with 4 weeks in between	No
Secondary	Lung function	spirometry and/or whole body plethysmography	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	Peripheral oxygenation level	Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No