Trial Outcomes & Findings for The Role of Ambulatory Oxygen in Improving the Effectiveness of Pulmonary Rehabilitation for COPD Patients (NCT NCT02707770)

Results Overview

6 Minute Walk Test (6MWT)- Distance in meters

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

0, 8weeks

Results posted on

2021-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Ambulatory Oxygen Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ambulatory Oxygen n=9 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)	Room Air n=10 Participants Patient will breath on room air during pulmonary rehabilitation programme	Total n=19 Participants Total of all reporting groups
Age, Continuous	73 years n=9 Participants	72 years n=10 Participants	72.5 years n=19 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	6 Participants n=10 Participants	8 Participants n=19 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	4 Participants n=10 Participants	11 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	9 participants n=9 Participants	10 participants n=10 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 0, 8weeks

6 Minute Walk Test (6MWT)- Distance in meters

Outcome measures

Outcome measures
Measure	Ambulatory Oxygen n=9 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air n=10 Participants Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Change in Functional Exercise Capacity Baseline -0	332 meters Interval 170.0 to 430.0	335 meters Interval 140.0 to 500.0
Change in Functional Exercise Capacity Post PR - 8weeks	346 meters Interval 200.0 to 430.0	340 meters Interval 140.0 to 510.0

SECONDARY outcome

Timeframe: 0,8weeks

Chronic Respiratory Questionnaire(CRQ)- Number of Participants achieving minimal clinically important difference (MCID) in CRQ compared between baseline and follow up assessment.

Outcome measures

Outcome measures
Measure	Ambulatory Oxygen n=9 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air n=10 Participants Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Number of Participants Reporting a Change in the Quality of Life	3 participants	2 participants

SECONDARY outcome

Timeframe: 0,8weeks

Hospital anxiety and depression score- Anxiety component (HADS-A)-Numbers of participants achieving Minimal clinically important difference in HADS-A compared between baseline and follow up assessment.

Outcome measures

Outcome measures
Measure	Ambulatory Oxygen n=9 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air n=10 Participants Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Number of Participants Reporting a Change in Anxiety Score	4 participants	3 participants

SECONDARY outcome

Timeframe: 0,8weeks

Hospital anxiety and depression score- Depression component (HADS-D)-Numbers of participants achieving Minimal clinically important difference in HADS-D compared between baseline and follow up assessment.

Outcome measures

Outcome measures
Measure	Ambulatory Oxygen n=9 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air n=10 Participants Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Number of Participants Reporting Change in Depression Score	2 participants	2 participants

SECONDARY outcome

Timeframe: 0,8weeks

Chronic Obstructive Pulmonary diseases Assessment Test (CAT score)-Numbers of participants achieving Minimal clinically important difference in CAT score compared between baseline and follow up assessment.

Outcome measures

Outcome measures
Measure	Ambulatory Oxygen n=9 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air n=10 Participants Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Number of Participants Reporting Change in Chronic Obstructive Pulmonary Diseases Assessment Test (CAT)	5 participants	3 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Due to technical problems identified with accuracy of device, this outcome measure was excluded from study

Pedometer- Number of step counts

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0,8 weeks

Handheld Muscle testing- Number of participants achieving Minimal clinical important difference in quadriceps muscle strength compared between baseline and follow up assessment

Outcome measures

Outcome measures
Measure	Ambulatory Oxygen n=8 Participants Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Pulmonary Rehabilitation	Room Air n=6 Participants Patient will breath on room air during pulmonary rehabilitation programme Pulmonary Rehabilitation
Number of Participants With Change in Quadriceps Muscle Strength	0 Participants	0 Participants

Adverse Events

Ambulatory Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Room Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

vijay padmanaban

Imperial college healthcare NHS trust

Phone: 02033122349

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place