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Innovation in Pulmonary Rehabilitation

Innovation Methods to Augment Pulmonary Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00123422
Enrollment
103
Registered
2005-07-22
Start date
2005-10-31
Completion date
2009-09-30
Last updated
2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Pulmonary Emphysema

Keywords

Breathing exercise, Exercise Therapy, Helium, Oxygen inhalation therapy, Pulmonary emphysema, Pulmonary ventilation, Rehabilitation

Brief summary

The purpose of this study was to compare the effect of exercise treatment combined with breathing retraining (a computerized feedback program), with exercise treatment combined with heliox (a helium and oxygen combination), with exercise only in patients with moderate to severe chronic obstructive pulmonary disease. This was an 8-week intervention study.

Detailed description

Dynamic hyperinflation limits exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). Recently, several innovative approaches have been developed to reduce the burden of dynamic hyperinflation. Two such innovations, ventilation-feedback training and Heliox supplementation during exercise show great promise and posit a reduction in dynamic hyperinflation as a key to their effectiveness. In our recently completed trial, when age, FEV1 and RV/TLC were controlled, exercise plus VF (E+VF) was superior to E training alone (E only) or VF training alone in improving exercise tolerance. The mechanism responsible for this difference was, in part, a reduction in exercise-induced dynamic hyperinflation secondary to a change in breathing pattern. In additional preliminary studies, we determined that exercise tolerance can be increased when patients exercise while inhaling Heliox. Similar to VF, the mechanism for exercise improvement with Heliox was a reduction in exercise-induced dynamic hyperinflation. Although both interventions are promising, there are no definitive data to support use of either intervention as a standard of care for pulmonary rehabilitation. Hypothesis/Research Questions Overview: The two primary hypotheses are that patients with moderate-severe COPD who successfully complete eight weeks of (a) E+VF training will achieve longer exercise duration than patients randomly assigned to E only and (b) E+heliox training will achieve longer exercise duration than patients randomly assigned to E only. Methods: This study was a randomized controlled clinical trial. After baseline testing is completed, 103 subjects with moderate-severe COPD were randomized into one of three groups: E+VF, E+Heliox and E training only. Follow-up testing was completed at 8 weeks. testing, activity monitoring, and dyspnea measurements. After baseline testing was completed, randomized subjects trained in the Physical Performance Laboratory three times weekly. Exercise prescriptions were standardized and based on data from the exercise stress test.

Interventions

exercise training with computerized training program

BEHAVIORALHeliox

exercise training with a helium oxygen combination

BEHAVIORALExercise

exercise training

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 40 years of age * FEV1 70% * FEV1/FVC \<70% * RV/TLC \> 120%

Exclusion criteria

* Respiratory infection/exacerbation within last 4 weeks * Exercise limiting heart disease * Primary asthma * Congestive heart failure New York Heart Association (NYHA) Class III-IV * Exercise limiting peripheral arterial disease or arthritis * Inability to walk on a treadmill

Design outcomes

Primary

MeasureTime frameDescription
Exercise Endurance14 weeksExercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.

Secondary

MeasureTime frameDescription
Inspiratory Capacity14 weeksInspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.

Countries

United States

Participant flow

Recruitment details

192 patients were screened for eligibility in the study. 103 patients were randomly assigned to the one of the 3 groups. Patients were not randomized for the following reasons: PFT did not qualify (n=47), cardiac problems (n=13), changed mind (n=9), non-compliant (n=6), time constraints (n=5), too debilitated (n=3), other (n=6).

Participants by arm

ArmCount
Breathing Retraining
Exercise training with computerized training program Breathing retraining: exercise training with computerized training program
35
Heliox
Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination
33
Exercise
Exercise training Exercise: exercise training
35
Total103

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up122
Overall StudyPhysician Decision226
Overall StudyWithdrawal by Subject122

Baseline characteristics

CharacteristicBreathing RetrainingHelioxExerciseTotal
Age, Continuous68 years
STANDARD_DEVIATION 10
70 years
STANDARD_DEVIATION 9
69 years
STANDARD_DEVIATION 7
69 years
STANDARD_DEVIATION 9
FEV1 percent predicted45 percent
STANDARD_DEVIATION 14
46 percent
STANDARD_DEVIATION 14
41 percent
STANDARD_DEVIATION 13
44 percent
STANDARD_DEVIATION 14
Region of Enrollment
United States
35 participants33 participants35 participants103 participants
RV/TLC percent predicted165 percent
STANDARD_DEVIATION 27
158 percent
STANDARD_DEVIATION 24
161 percent
STANDARD_DEVIATION 24
161 percent
STANDARD_DEVIATION 25
Sex: Female, Male
Female
2 Participants2 Participants1 Participants5 Participants
Sex: Female, Male
Male
33 Participants31 Participants34 Participants98 Participants
Smoking history62 pack/years
STANDARD_DEVIATION 37
67 pack/years
STANDARD_DEVIATION 40
68 pack/years
STANDARD_DEVIATION 48
64 pack/years
STANDARD_DEVIATION 42

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
1 / 352 / 331 / 35
serious
Total, serious adverse events
1 / 350 / 335 / 35

Outcome results

Primary

Exercise Endurance

Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.

Time frame: 14 weeks

Population: We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.

ArmMeasureValue (MEAN)Dispersion
Breathing RetrainingExercise Endurance18.1 minutesStandard Deviation 13.4
HelioxExercise Endurance14.5 minutesStandard Deviation 10.7
ExerciseExercise Endurance11.5 minutesStandard Deviation 7
p-value: 0.015ANCOVA
Secondary

Inspiratory Capacity

Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.

Time frame: 14 weeks

Population: Intent-to-treat analysis was used so data on all randomized patients were analyzed.

ArmMeasureValue (MEAN)Dispersion
Breathing RetrainingInspiratory Capacity2.4 LitersStandard Deviation 0.7
HelioxInspiratory Capacity2.0 LitersStandard Deviation 0.6
ExerciseInspiratory Capacity2.1 LitersStandard Deviation 0.7
p-value: <0.05ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026