跳至主要内容
临床试验/NCT03799354
NCT03799354招募中不适用

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

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Change in walking efficiency

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Treatment Group

Experimental

Maximal strenght training (MST) plus endurance training (ET)

干预措施: Maximal strenght training (MST) plus endurance training (ET) (Other)

Control group

Active Comparator

Endurance training (ET)

干预措施: Endurance training (ET) (Other)

结局指标

主要结局

Change in walking efficiency

时间窗: baseline and 8 weeks

The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2). After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline. Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100.

次要结局

  • Change in Leg Strength by 1-Repetition Maximum on leg press(baseline and 8 weeks)
  • Change in Falls(baseline and 8 months)
  • Change in Dyspnea(baseline and 8 weeks)
  • Muscular proteolyses by 3-MeH concentration(baseline and 8 weeks)
  • Patient Satisfaction: Likert Scale(at 8 weeks)
  • Change in maximal Rate of Force Development (RFD)(baseline and 8 weeks)
  • Change in Constant Load Effort tolerance(baseline and 8 weeks)
  • Change in Fatigue (physiological evaluation)(baseline and 8 weeks)
  • Change in Fatigue (qualitative evaluation)(baseline and 8 weeks)
  • Change in Muscle volume(baseline and 8 weeks)
  • Concentration of CRP(baseline and 8 weeks)
  • Concentration of Interleukin-6(baseline and 8 weeks)
  • Change in maximal effort tolerance(baseline and 8 weeks)
  • Change in Low grade Inflammation(baseline and 8 weeks)
  • Concentration of Tumor necrosis factor alpha(baseline and 8 weeks)
  • Change in Balance (qualitative measure)(baseline and 8 weeks)
  • Change in quality of life(baseline and 8 weeks)
  • Hospitalizations(baseline and 8 months)
  • Mortality(baseline and 8 months)
  • Change in Balance (quantitative measure)(baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验