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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Pulmonary rehabilitation
    • Multi-disciplinary pulmonary rehabilitation

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LHL Helse
  • Collaborator
    • Lovisenberg Diakonale Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne Edvardsen, PhD, Principal Investigator, LHL-klinikkene Glittre

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