Beta-alanine supplementation in patients with COPD receiving non-linear periodized exercise (NLPE) training: randomized placebo-controlled trial.

Withdrawn

Conditions: chronic obstructive pulmonary disease
chronic lungdisease with persistent obtsruction of the airways
10006436

Registration Number: NL-OMON49690

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 154

Inclusion Criteria

1. COPD group B or D (high symptomatic)
2. Grade 2 or higher on the modified Medical Medical Research Council (mMRC)
3. Clinically stable on the basis of clinical picture by pulmonary physician,
i.e. no exacerbation and/or hospitalization within the previous 4 weeks
4. Age between 40-80 years
5. Attending the regular rehabilitation program in Dekkerswald or CIRO and
receiving NLPE.
6. No use of anabolic steroids during the inpatient pulmonary rehabilitation
program in Dekkerswald and CIRO.

Exclusion Criteria

1. Instable cardiac disease.
2. Participants treated with Neuromuscular Eletrical Stimulation (NMES)
3. History of drugs/alcohol abuse
4. Vegetarianism
5. Inability to understand the Dutch language
6. Self-reported beta-alanine supplementation in the past 3 months (wash-out
period is set at 9 weeks).
7. Participation in pulmonary rehabilitation within the past 12 months.
8. Inability to perform the incremental shuttle walk test

If the patient agrees to undergo a muscle biopsy, the following exclusion
criterion will also apply:
9. Patients with bleeding disorders, a recent trauma of the muscle or an
infection in the region of the proposed biopsy will be excluded for the muscle
biopsies.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is exercise tolerance, determined with the<br /><br>endurance shuttle walk test as the walking endurance time.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are cycle endurance time, lower-limb muscle<br /><br>function, muscle and systemic carnosine, taurine, beta-alanine and histidine,<br /><br>muscle and systemic oxidative stress and inflammation, dyspnoea, fatigue,<br /><br>physical activity, symptoms of anxiety and depression, body composition,<br /><br>cognitive function, respiratory muscle strength and disease-specific quality of<br /><br>life. Furthermore, the therapy adherence and patient safety will be assessed.</p><br>