CompletedNAResults postedLast updated 13 February 2024
What this trial tests
NA trial testing Home Based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) in 375 participants. Completed in 16 February 2022.
Adults 40 to 99, any sex, with Chronic Obstructive Pulmonary Disease (COPD) or Emphysema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Quality of LifePrimary· Baseline, 3 months
The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clini
CRQ Physical
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
0.37
0.24 – 0.51
Usual Care
-0.17
-0.29 – 0.05
CRQ Emotional
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
0.43
0.29 – 0.57
Usual Care
-0.08
-0.2 – 0.05
Change in Self-management AbilitiesSecondary· Baseline, 3 months
Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
3.84
2.44 – 5.24
Usual Care
0.54
-0.62 – 1.71
Change in Physical ActivitySecondary· Baseline, 3 months
The change in average daily activity (measured in minutes) for the top 3 to 5 most active days during the measured period. Measured by the Actigraph GT3X .
Daily Light Physical Activity
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
17.51
4.54 – 30.49
Usual Care
0.6
-13.22 – 14.42
Daily Moderate Physical Activity
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
4.47
-3.17 – 12.11
Usual Care
-4.82
-11.66 – 2.01
Change in Daily Step CountsSecondary· Baseline, 3 months
Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
478.63
108.02 – 849.25
Usual Care
-146.53
-458.5 – 165.44
Change in DepressionSecondary· Baseline, 3 months
Measured by the Patient Health Questionnaire-9 item questionnaire screening for depression. Total score range from 0 to 27. A higher score indicates that depression may be present.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
-1.12
-1.67 – -0.58
Usual Care
0.08
-0.46 – 0.62
Social SupportSecondary· Baseline, 3 months
Measured by the Interpersonal Support Evaluation List (ISEL-12) a 12-item measure of perceptions of social support utilizing three different subscales designed to measure three dimensions of f perceived social support (appraisal support, beloning support, and tangible support). Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". Total score range 0-36 with a higher score indicating greater social support.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
0.58
-0.16 – 1.32
Usual Care
-0.04
-0.72 – 0.63
Meaning in LifeSecondary· Baseline, 3 months
Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
0.07
-0.68 – 0.82
Usual Care
-0.33
-1.13 – 0.48
Change in Sleep QualitySecondary· Baseline, 3 months
Measured using the Pittsburgh Sleep Quality Index to assess severity of sleep disturbances. 9 item questionnaire with total possible scores range from 0 to 21. A lower score suggests a better quality of sleep and a higher score indicates a worse outcome/more severe symptoms of disturbance.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
-0.72
-1.09 – -0.34
Usual Care
0.03
-0.36 – 0.42
Change in AnxietySecondary· Baseline, 3 months
Measured using the General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0 to 6.,A higher score suggests that anxiety is present.
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
-0.42
-0.68 – -0.15
Usual Care
-0.24
-0.57 – 0.09
Healthcare UtilizationSecondary· 3 months
Number of subjects to have an emergency room visits or hospitalization.
Any Emergency Room Visit
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
13
Usual Care
24
Any Hospitalization
Group
Value
95% CI
Pulmonary Rehabilitation Program Intervention
15
Usual Care
15
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07519603 — Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program
· NA
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 13 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03480386.