Trial Outcomes & Findings for Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00677690)

Results Overview

6 minute walk test(6MWT)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

83 participants

Primary outcome timeframe

5 weeks

Results posted on

2011-11-16

Participant Flow

2007-2008 - Rehabilitative Pulmonary ward

167 COPD patients were admitted.52 out of 167 did not meet the inclusion criteria.19 out of the remaining 115 patients refused to participate.13 out of 96 subjects subsequently dropped out due to acute exacerbation.Our definitive sample was therefore of 83 subjects

Participant milestones

Participant milestones
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation Patients undergone to pulmonary rehabilitation
Overall Study STARTED	42	41
Overall Study COMPLETED	42	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation n=42 Participants Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation n=41 Participants Patients undergone to pulmonary rehabilitation	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Age Continuous	61.4 years STANDARD_DEVIATION 7.6 • n=5 Participants	62.8 years STANDARD_DEVIATION 5.4 • n=7 Participants	62.1 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment Italy	42 participants n=5 Participants	41 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

6 minute walk test(6MWT)

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation n=42 Participants Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation n=41 Participants Patients undergone to pulmonary rehabilitation
Exercise Capacity	465.5 meters Standard Deviation 101.7	462.7 meters Standard Deviation 96.9

PRIMARY outcome

Timeframe: 5 weeks

Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation n=42 Participants Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation n=41 Participants Patients undergone to pulmonary rehabilitation
Quadriceps Strength	13.5 repetitions Standard Deviation 0.83	13.6 repetitions Standard Deviation 0.99

SECONDARY outcome

Timeframe: 5 weeks

The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation n=42 Participants Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation n=41 Participants Patients undergone to pulmonary rehabilitation
Dyspnoea	2.4 units on a scale Standard Deviation 0.4	2.6 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 5 weeks

St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation n=42 Participants Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation n=41 Participants Patients undergone to pulmonary rehabilitation
Quality of Life	41.7 units on a scale Standard Deviation 14.8	42.05 units on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: 5 weeks

forced expiratory volume in 1 second (FEV1)

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulation and Pulmonary Rehabilitation n=42 Participants Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Pulmonary Rehabilitation n=41 Participants Patients undergone to pulmonary rehabilitation
Respiratory Function	50.1 percentage of predicted value Standard Deviation 6.4	49.6 percentage of predicted value Standard Deviation 8.2

Adverse Events

Neuromuscular Stimulation and Pulmonary Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pulmonary Rehabilitation

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

Ercole Zanotti

Fondazione Salvatore Maugeri, IRCCS, Pavia, Italy

Phone: 39 385 247

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place