Training-induced Muscle Strength Increase and Its Role in Interface Pressure in Inelastic Compression: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Change from baseline handgrip strength at 12 weeks
研究概览
简要总结
The present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression?
详细描述
This phase I two-armed randomized clinical trial including participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in resistance exercise programs will be conducted at the Ativas Gym, Xanxere/SC, Brazil. Participants will perform exercises during the strength-training protocol intervention, while individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. In addition, we will monitor their eating and physical activity habits throughout the data collection period. The study was designed in accordance with the CONSORT statement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Researchers who will perform both pre and post-test evaluations, as well as data analysis, will be blinded regarding randomization. Blinding will be ensured by asking investigators at the end of the trial if investigators knew the arm to which each subject will be allocated prior to opening the envelope.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs.
排除标准
- •Participants who present chronic venous insufficiency (CEAP C3-6) evaluated through Doppler ultrasonography, severe congestive heart failure (functional class III and IV - NYHA), and Ankle/Brachial Index (ABI) < 0.
- •We will also exclude elderly individuals who are unable to perform the required exercises due to physical limitations and those bedridden or wheelchair-bound.
结局指标
主要结局
Change from baseline handgrip strength at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
We will perform the handgrip test assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants. We will use a dynamometer in the sitting position, with the shoulder slightly adducted, elbow flexed to 90º, forearm in a neutral position, and, finally, the position of the wrist can vary from 0 to 30º of extension. Three 3-second isometric muscle contractions will be performed, in order to record the handgrip strength obtained (Fernandes \& Marins, 2011).
Change from baseline body composition at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
The body composition assessment will be performed through Dual-Energy X-Ray Absorptiometry (DXA) examination, on the first and last day of the study, in both groups, with the participant fasting, without having exercised in the last 24 hours (Andreoli et., 2009).
Change from baseline muscle strength at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
Muscle strength assessments will be performed at the beginning and end of the intervention (pre-test and post-test) in all study participants. After warming up the lower limbs, based on dynamic movements, for three minutes, each participant will perform between six and eight repetitions with 50% of the estimated maximum load and, one minute later, three repetitions with 70% of the estimated load. Three minutes after the specific warm-up, the test will start. An interval of two minutes will be considered between each attempt, and no more than five attempts will be made for each participant. The load corresponding to the last successful attempt will be considered as a result (Brown \& Weir, 2001).
Change from baseline interface pressure at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
We will measure the interface pressure exerted by the bandage/velcro device at point B1 (the area located at the transition between the Achilles tendon and the muscular portion of the medial gastrocnemius muscle). We will perform the interface pressure assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants using a PicoPress pneumatic system.
Change from baseline Static Stiffness Index at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
Static Stiffness Index will be calculated by the difference in the interface pressure measure between the supine and standing positions, at the beginning and end of the intervention (pre-test and post-test).
Change from baseline walking speed at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
We will perform walking speed assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants. Will be evaluated through the test of walking speed of 4 meters, participants will perform the test walking with normal stride speed throughout the course (Braden, 2012).
Change from baseline Working Pressure Amplitude at 12 weeks
时间窗: Baseline visit and follow-up after 12 weeks
Working Pressure Amplitude (WPA) will be considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements of the ankle joint and during walking. And will be performed at the beginning and end of the intervention (pre-test and post-test).
次要结局
- Change from baseline lower limbs' functional strength at 12 weeks(Baseline visit and follow-up after 12 weeks)
- Change from quality of life assessment at 12 weeks(Baseline visit and follow-up after 12 weeks)
- Change from baseline dynamic balance at 12 weeks(Baseline visit and follow-up after 12 weeks)