Training-induced Muscle Strength and Its Role in Interface Pressure in Inelastic Compression

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Training-induced Muscle Strength Increase and Its Role in Interface Pressure in Inelastic Compression: A Randomized Clinical Trial

Conditions
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Resistance Training

Intervention / Treatment
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* Other: resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs. Exclusion Criteria: 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) < 0.8. We will also exclude elderly individuals who are unable to perform the required exercises due to physical limitations and those bedridden or wheelchair-bound.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: resistance training<br>Participants will not be offered the exercise program in the three months before data collection. From then on, participants will perform exercises during the resistance training protocol intervention. | Other: resistance training<br>* Interventions will include a three-phase strengthening training protocol. Adaptation phase: three sessions, emphasis on learning the technique, body self-awareness, and movement coordination; Basic phase: 12 sessions, to increase muscle strength; and Specific phase: 21 sessions, to intensify the process of strength gain and muscular hypertrophy. Participants will perform the following exercises during the strength-training protocol intervention: pec deck/seated lever fly, adductor, pulldown, abductor strengthening, alternating dumbbell curl, leg press at a 45-angle, triceps pulley, lateral raise, knee flexion and extension, ankle joint flexion and extension in the leg press, and crunches. If the participant has difficulty performing a specific exercise, an equivalent activity will replace it. From the eighth week onwards, participants will perform additional exercises focused on strengthening the gastrocnemius and soleus.<br>|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline body composition at 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). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline muscle strength at 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). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline handgrip strength at 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). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline walking speed at 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). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline interface pressure at 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. | Baseline visit and follow-up after 12 weeks | 
| Change from baseline Static Stiffness Index at 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). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline Working Pressure Amplitude at 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). | Baseline visit and follow-up after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from quality of life assessment at 12 weeks | The Short-Form 36 (SF-36) questionnaire will be used; scores will be assigned to each question. Changing the scale from zero to 100, values closer to zero being considered a negative perception of quality of life and close to 100 as a positive perception of quality of life (Ciconelli et al., 1999). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline lower limbs' functional strength at 12 weeks | We will evaluate lower limbs' functional strength at the beginning and end of the intervention (pre-test and post-test) in all study participants. Using the Chair-test, it will be measured using a chair without armrests with a seat height of approximately 43 cm from the floor. The test will start with the participant sitting in the middle of the chair. At the signal, the participant will rise to full extension of the knee joint (upright body) and then return to the starting sitting position (Jones et al., 1999). | Baseline visit and follow-up after 12 weeks | 
| Change from baseline dynamic balance at 12 weeks | It will be performed using the timed up and go test. The test consists of getting up from a chair, going around a cone three meters away, and sitting back down on the chair. The time it takes the subject to get up from a chair, walk, return to the chair and sit down again is recorded (Podsiadlo & Richardson, 1991). | Baseline visit and follow-up after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inelastic compression, Resistance exercise, Muscle hypertrophy, Chronic venous disease