| Study characteristics |
| Methods |
Study design: RCT
Study grouping: parallel‐group
Subgroup analysis: FEV1 > or ≤ 50% of the predicted value |
| Participants |
Baseline characteristics
PR+IMT
N (randomized/analyzed): 16/16 Loss to follow‐up or excluded: 0 Age, mean (SD), in years: 62 (10) Gender (M/F): 4/12 BMI mean (SD), kg/m²: 27.3 (4.2)
PR
N (randomized/analyzed): 18/16 Loss to follow‐up or excluded: 0 Age, mean (SD), in years: 61 (8) Gender (M/F): 7/11 BMI mean (SD), kg/m²: 26.8 (6.0)
Overall
N (randomized/analyzed): 34/32 Loss to follow‐up or excluded: 0 Gender (M/F): 11/23 COPD stage (GOLD): moderate to very severe
Included criteria
COPD diagnosed according to American Thoracic Society/European Respiratory Society criteria;
PImax > 60 cmH2O at admission.
Excluded criteria
Previous pneumonectomy or lobectomy in the past 6 months; Impossibility to measure IC at the end of the 6MWD; The incapacity to follow the standard rehabilitation program; The absence of written informed consent.
Pretreatment: FEV 1 was lower in the IMT group; the Borg scale was higher in the control group. |
| Interventions |
Intervention characteristics
PR+IMT
PR: conducted for 3 weeks, 5 d/week, and included aerobic exercise on a cycle ergometer and a treadmill (30 min/d each), strengthening of lower and upper limb muscle groups, therapeutic educational program, aerobic gymnastics in groups, smoking cessation program, and socio‐psychological and dietary advice. IMT: performed daily in 2 sessions of 15 min each, 5 times/week, for 3 weeks, supervised by a physiotherapist. The participants had to breathe slowly with an increased tidal volume. A threshold inspiratory muscle trainer (Threshold IMT1) was used at 40% of PImax. The intensity was not modified during the program.
PR
Participants in this group received only the standardised PR program. |
| Outcomes |
Dyspnea: Borg
Dyspnea: MDP
Unpleasantness Sensory intensity Muscle work/effort Not enough air/smother/air hunger Mental effort/concentrate Tight/constricted Breathing a lot (rapid, deep, and heavy) Crush Depression Satisfaction Anxiety Frustration Anger Happiness Fear
Functional exercise capacity: 6MWD
Respiratory muscle strength: PImax |
| Identification |
Sponsorship source: EA3878 (G.E.T.B.O.), CIC INSERM 0502, University Hospital of Brest
Country: France
Setting: Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, European University of Occidental Brittany
Author's name: Marc Beaumont
Institution: Pulmonary Rehabilitation Unit, Morlaix HospitalCentre, European University of Occidental Brittany
Email: marc.beaumont@univ‐brest.fr
Address: Morlaix29672, Cedex, France
Clinical trial register: NCT01545011
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| Notes |
P‐value of the change from baseline is from the adjusted analysis. |
