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Effects of resistance training or NMES in COPD.


- candidate number8054
- NTR NumberNTR2322
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mei-2010
- Secondary IDsNL30153.068.09 / MEC 09-3-072 MEC azM/UM
- Public TitleEffects of resistance training or NMES in COPD.
- Scientific TitleEffects of resistance training or neuromuscular electrical stimulation in patients with chronic obstructive pulmonary disease.
- ACRONYMEffects of resistance training or NMES in COPD
- hypothesisH0: High-intensive resistance training and high-frequency NMES show comparable effects on skeletal muscle strength, exercise capacity and health-related quality of life in COPD patients who are characterized by dyspnoea and muscle dysfunction of the lower limbs.

H1: High-intensive resistance training and high-frequency NMES do not show comparable effects on skeletal muscle strength, exercise capacity and health-related quality of life in COPD patients who are characterized by dyspnoea and muscle dysfunction of the lower limbs.

H0: Low-frequency NMES and high-frequency NMES show comparable effects on skeletal muscle strength, exercise capacity and health-related quality of life in COPD patients who are characterized by dyspnoea and muscle dysfunction of the lower limbs.

H1: Low-frequency NMES and high-frequency NMES do not show comparable effects on skeletal muscle strength, exercise capacity and health-related quality of life in COPD patients who are characterized by dyspnoea and muscle dysfunction of the lower limbs.

H0: Low-frequency NMES and high-intensive resistance training show comparable effects on skeletal muscle strength, exercise capacity and health-related quality of life in COPD patients who are characterized by dyspnoea and muscle dysfunction of the lower limbs.

H1: Low-frequency NMES and high-intensive resistance training do not show comparable effects on skeletal muscle strength, exercise capacity and health-related quality of life in COPD patients who are characterized by dyspnoea and muscle dysfunction of the lower limbs.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD)
- Inclusion criteria1. Primary diagnosis of COPD;
2. No acute COPD exacerbations in the past 4 weeks;
3. Baseline MRC dyspnoea grade 4 or 5;
4. Quadriceps weakness (isokinetic knee extension peak torque <75% predicted);
5. Voluntary authorisation for participation.
- Exclusion criteria1. Neuromuscular diseases;
2. Joint disorders in hip, leg and/or knee;
3. Metal implants in hip, leg and/or knee;
4. Cardiac pacemaker or Internal Cardiac Defibrillator (ICD);
5. Demotivated to participate in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate31-dec-2012
- Target number of participants120
- InterventionsPatients will be randomised to one of the three groups. The intervention will be given 2 times a day, 5 times a week during 8 weeks. The interventions are:
1. Resistance training;
2. High-frequency neuromuscular electrical stimulation:;
3. Low-frequency neuromuscular electrical stimulation.

Resistance training:
A resistance training session (17) will consist of bilateral leg extension and bilateral leg press exercises. These exercises will be performed at 70% of 1-repetition maximum (1RM), 4x8 repetitions per exercise with at least 2 minutes of recovery between each set. The 1RM will be determined in the begin-assessment to adjust the training load. Each two weeks will be tried to increase the training load with 5%.

NMES:
During the NMES, the quadriceps femoris muscles and calf muscles of both legs will be electrically stimulated with a portable electrical stimulator (Tensmed S84, Enraf- Nonius, Rotterdam, the Netherlands). A total of 8 carbon-rubber electrodes will be placed on the leg muscles (4 electrodes on each leg): two on the quadriceps femoris muscles and two on the calf muscles. In both NMES protocols a symmetrical biphasic square pulse will be used with a pulse time of 400 microseconds, a duty cycle of 8 seconds on and 8 seconds off, intensity adjusted to individual toleration during a session lasting 21 minutes. The frequencies which will be used are respectively 75 Herz in high-frequency NMES and 15 Herz in low-frequency NMES.
- Primary outcomeQuadriceps muscle function: Peak strength and endurance.
- Secondary outcome1. Health status (St. George's Respiratory Questionnaire, SGRQ);
2. Functional exercise capacity (6-minute walking test, 6MWT);
3. Exercise tolerance (constant work-rate cycling endurance test);
4. Body composition (body mass index, fat free mass index) (whole-body dual-energy x-ray absorptiometry scan, DEXA scan);
5. Dyspnoea (MRC dyspnoea scale);
6. Metabolic load (oxygen uptake and ventilation) (Oxycon Mobile, VIASYS Healthcare,the Netherlands);
7. Changes in vastus lateralis fiber type shift, fiber cross sectional area and enzyme activity (muscle biopsy).
- Timepoints1. Begin-assessment, end-assessment and follow-up after 6 months: Pulmonary function, muscle function, health status, functional exercise capacity, exercise tolerance, body composition and dyspnoea (MRC);
2. Week 1, 4 and 8 of the study: In sub-group measurements metabolic load;
2. Week 1 and 8: In sub-group muscle biopsies.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Sillen
- CONTACT for SCIENTIFIC QUERIES M. Sillen
- Sponsor/Initiator CIRO+ (Centre of expertise for chronic organ failure)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Asthma Foundation, The Weijerhorst Foundation, Maastricht, the Netherlands
- Publications1. Sillen MJ, Janssen PP, Akkermans MA, Wouters EF, Spruit MA. The metabolic response during resistance training and neuromuscular electrical stimulation (NMES) in patients with COPD, a pilot study. Respir Med 2008 May;102(5):786-9 .
2. Sillen MJ, Speksnijder CM, Eterman RM, Janssen PP, Wagers SS, Wouters EF, Uszko-Lencer HM, Spruit MA. Effects of neuromuscular electrical stimulation of muscles of ambulation in patients with chronic heart failure or COPD: A systematic review of the English-language Literature. Chest 2009 Apr; 136(4):44-61.
3. Sillen MJ, Wouters EF, Franssen FME, Spruit MA. Resistance training and neuromuscular electrical stimulation during acute exacerbations of chronic obstructive pulmonary disease. Int J Respir Care 2009 May; 5(1): 14-16.
4. Sillen MJ, Wouters EF, Franssen FME, Meijer K, Stakenborg KHP, Spruit MA. Oxygen uptake and ventilation during high-frequency versus low-frequency neuromuscular electrical stimulation in COPD, a pilot study. Submitted.
- Brief summaryBackground of the study:
Resistance training (RT) and transcutaneous neuromuscular electrical stimulation (NMES) are relative new rehabilitative modalities in COPD. Because dyspnoeic COPD patients with quadriceps weakness are limited to fulfil endurance training, it seems reasonable to add interventions at pulmonary rehabilitation programs without evoking exercise-induced dyspnoea.

Objective of the study:
The objective is to compare the effects of RT, high-frequency NMES and low frequency NMES in dyspnoeic COPD patients with quadriceps weakness.

Methods:
A randomized controlled trial has been designed to study changes in quadriceps strength and endurance. Secondary outcomes will be health status, functional exercise capacity, exercise tolerance, body composition, dyspnoea, metabolic response, changes in muscle fiber type shift, fiber cross sectional area and enzyme activity.
- Main changes (audit trail)
- RECORD11-mei-2010 - 28-mei-2010


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