The primary objective is to compare the effects of daily beta-alanine supplementation or a placebo supplement on exercise tolerance (walking endurance time) in patients with COPD receiving NLPE.The secondary objectives are:• to determine the effects…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is exercise tolerance, determined with the
endurance shuttle walk test as the walking endurance time.
Secondary outcome
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.
Background summary
Physical inactivity and oxidative stress have been identified as the two main
causes of reduced quadriceps muscle strength and endurance, two well-known
disabling extra-pulmonary features in patients with Chronic Obstructive
Pulmonary Disease (COPD). In healthy untrained elderly subjects, oral
beta-alanine supplementation (without exercise training) is powerful in
increasing muscle carnosine content and exercise capacity by 13-29%. It is very
plausible to hypothesize that increased muscle carnosine levels will have a
positive effect on lower-limb muscle function and exercise tolerance in COPD,
by buffering pH and scavenging Reactive Oxygen Species (ROS). To date,
non-linear periodized exercise (NLPE) training is one of the best strategies to
improve lower-limb muscle function and exercise tolerance in COPD patients with
explicit functional limitations and high symptom burden. Beta-alanine
supplementation is expected to augment the effects of exercise-based
rehabilitation on lower-limb muscle function, exercise tolerance, oxidative
stress, fatigue, physical activity, and quality of life in COPD patients.
Study objective
The primary objective is to compare the effects of daily beta-alanine
supplementation or a placebo supplement on exercise tolerance (walking
endurance time) in patients with COPD receiving NLPE.
The secondary objectives are:
• to determine the effects of beta-alanine supplementation in patients with
COPD receiving NLPE on cycle endurance time, lower-limb muscle function, muscle
and systemic carnosine, taurine, beta-alanine and histidine, muscle and
systemic oxidative stress and inflammation, fatigue, dyspnoea, symptoms of
anxiety and depression, body composition, physical activity, cognitive
function, respiratory muscle strength, disease-specific quality of life and
patient safety and therapy adherence.
• to evaluate the correlation between the change in carnosine levels and change
in exercise tolerance, lower-limb muscle function and oxidative stress and
inflammation after 8 weeks of daily oral beta-alanine supplementation in
patients with COPD receiving NLPE.
Study design
Prospective, randomized, double-blind, placebo-controlled, multi-centre study.
Intervention
Oral beta-alanine supplementation (sustained-release CarnoSyn®; 3.2 g/day) or
placebo for 8 - 10 weeks.
Study burden and risks
BURDEN: In addition to standard care (NLPE as part of regular pulmonary
rehabilitation program at Dekkerswald and CIRO), participants are asked to
perform additional measurements (venous blood sampling, muscle biopsy and 2
cognitive function tests) on 2 separate days (1 day before and 1 day after the
rehabilitation). Furthermore, participants have to take supplements on a daily
basis for 8-10 weeks.
RISKS: The proposed dose of sustained release beta-alanine (SR CarnoSyn®; 3.2
g/day) is proven effective in healthy adults and elderly, without any side
effects. Complications of vastus lateralis muscle biopsy may include infection,
bleeding and hematoma formation. These complications are rare (<1.5%) if the
test is performed properly under semi-sterile conditions. Venous blood sampling
is associated with a 5% risk of developing local haemorrhage. However, this
will disappear within 2 weeks and is not associated with (functional)
limitations.
BENEFIT: Irrespective of treatment allocation, both groups will benefit from
participating in the pulmonary rehabilitation program. Beta-alanine is known to
be effective in increasing muscle carnosine content in both healthy young
adults and elderly subjects, with subsequent improvement in their exercise
capacity and has the potential to reduce oxidative stress and improve cognitive
function. So combining exercise-based rehabilitation with beta-alanine
supplementation has the potential to increase exercise tolerance and quality of
life of patients with COPD to a greater extent than exercise training alone.
GROUP RELATEDNESS: This will be the first study in which oral beta-alanine
supplementation will be combined with a pulmonary rehabilitation program in
COPD patients
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70781.091.19 |
| OMON | NL-OMON23943 |