Study on Impact of Maximal Strength Training in Patients With COPD

Официальное название

Study on Impact of Maximal Strength Training in Patients With COPD: Physiological and Clinical Implications

Обзор

In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events. Maximal Strength Training (MST) is a kind of RT typically performed at \~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations. When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency. Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).

Подробное описание

Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.

As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM).

Maximal Strength Training (MST) is a RT typically performed at \~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.

When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.

Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions.

In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance.

The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).

Вмешательства

• Другое Maximal strenght training (MST) plus endurance training (ET)
  Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of: 1. MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength trai
• Другое Endurance training (ET)
  Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-dow

Первичные конечные точки

• Change in walking efficiency [Срок оценки: baseline and 8 weeks]

Вторичные конечные точки (12)

• Change in Leg Strength by 1-Repetition Maximum on leg press [Срок оценки: baseline and 8 weeks]
• Change in maximal Rate of Force Development (RFD) [Срок оценки: baseline and 8 weeks]
• Change in maximal effort tolerance [Срок оценки: baseline and 8 weeks]
• Change in Constant Load Effort tolerance [Срок оценки: baseline and 8 weeks]
• Change in Fatigue (physiological evaluation) [Срок оценки: baseline and 8 weeks]
• Change in Fatigue (qualitative evaluation) [Срок оценки: baseline and 8 weeks]
• Change in Muscle volume [Срок оценки: baseline and 8 weeks]
• Change in Dyspnea [Срок оценки: baseline and 8 weeks]
• Concentration of CRP [Срок оценки: baseline and 8 weeks]
• Change in Low grade Inflammation [Срок оценки: baseline and 8 weeks]
• Concentration of Tumor necrosis factor alpha [Срок оценки: baseline and 8 weeks]
• Concentration of Interleukin-6 [Срок оценки: baseline and 8 weeks]

Критерии участия

Критерии включения

• COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) < 70%, and FEV1 < 50% of predicted
• stable clinical condition

Критерии исключения

• pulmonary diseases other than COPD
• type II diabetes or other metabolic diseases
• malign disease
• a respiratory tract infection within the last 4 wks
• long oxygen therapy use.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane — Lumezzane

Публикации

• Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Res PMID 24787074
• Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016. PMID 10378915
• Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39. PMID 17277584
• Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x. PMID 19804581

Идентификаторы

NCT: NCT03799354 · ICS Maugeri CE 2241

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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