Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial

Abstract

BackgroundLight-emitting diodes (LED) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue.ObjectiveThe objective of this study is to investigate the acute effects of LED on muscle function, exercise capacity and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD.MethodsThis study will assess 30 patients with moderate to severe obstruction (forced expiratory volume-one second,FEV1 ≤70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week apart. First, venous blood will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application (each point will be irradiated for 30 s and the energy received at each point will be 41.7 J). Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood draw will be taken. In another visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic endurance test (DET), the same procedures described above will be followed, except with 75% of the maximal workload obtained from the incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.Trial registrationTrial registration number: NCT01448564

Tailored implementation of cardiovascular risk management in general practice: a cluster randomized trial

“…There are several alternative explanations for the lack of effects. In process evaluations, we will report on the outcomes of interviews and questionnaires with practice nurses and a sample of patients, and on scoring of knowledge and motivational interviewing skills [ 10 , 24 ]. In general, we can hypothesize that failure of effectiveness might be due to lack of relevance of determinants or strategies, wrong prioritizing, or inadequate intervention delivery.…”

“…On the basis of the findings of this trial, we cannot recommend broad implementation of the tested improvement program. In a process evaluation of the trial, we will explore the impact of interventions on the addressed determinants of practice [ 10 ]. This will provide further insight into the validity of the interview methods, which were used in the development of the implementation program.…”

“…An open-label, two-arm, cluster randomized trial was conducted in the years 2013 and 2014 in the Netherlands [ 10 ]. The study was part of the international TICD project [ 11 ].…”

“…The last item was an elaboration of the recommendation in the guideline on cardiovascular risk management “to consider relevant co-morbidities.” It suggested to treat major depression before giving any lifestyle advice and to promote physical exercise rather than any other lifestyle in patients with mild depressive symptoms. A detailed description of the implementation program has been published in the study protocol [ 10 ]. General practices in the control arm of the study provided usual care and were offered a delayed intervention after the follow-up measurements had been completed.…”