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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49690
Enrollment
154
Registered
2020-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

chronic obstructive pulmonary disease

Interventions

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary study parameter is exercise tolerance, determined with the endurance shuttle walk test as the walking endurance time.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)