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

NCT05023642 | Completed

• 1 other identifier: Strengthinelastic
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Resistance Training

Keywords

Inelastic compression; Resistance exercise; Muscle hypertrophy; Chronic venous disease

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Change from quality of life assessment at 12 weeks

  Baseline visit and follow-up after 12 weeks

• Change from baseline lower limbs' functional strength 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

Study Arms (2)

resistance training

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

resistance training OTHER

Interventions will include a three-phase strengthening training protocol. 1. Adaptation phase: three sessions, emphasis on learning the technique, body self-awareness, and movement coordination; 2. Basic phase: 12 sessions, to increase muscle strength; and 3. 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.

resistance training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pró Circulação®: lead

Study Sites (2)

Unochapecó University

Chapecó, Santa Catarina, 89.809-900, Brazil

Location

Pró Circulação® - Clinic of Angiology and Vascular Surgery

Xanxerê, Santa Catarina, 89.820-000, Brazil

Location

Related Publications (10)

• Andreoli A, Scalzo G, Masala S, Tarantino U, Guglielmi G. Body composition assessment by dual-energy X-ray absorptiometry (DXA). Radiol Med. 2009 Mar;114(2):286-300. doi: 10.1007/s11547-009-0369-7. Epub 2009 Mar 5. English, Italian.

  PMID: 19266259 BACKGROUND

• Brown LE, Weir JP. Asep procedures recommendation I: accurate assessment of muscular strength and power. Journal of Exercise Physiology Online. 2001;4:1-21.

  BACKGROUND

• Fernandes, A.A., Marins, J.C.B.. Teste de força de preensão manual: analise metodológica e dados normativos em atletas. Fisoter Mov. 2011;24(3):567-78.

  BACKGROUND

• Braden, H. Self-selected gait speed: A critical clinical outcome. Lower Extremity Review. 2012 Nov.

  BACKGROUND

• Ciconelli, RM, et al. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Ver Bras Reumatol. 1999;39(3):143-150.

  BACKGROUND

• Yim E, Richmond NA, Baquerizo K, Van Driessche F, Slade HB, Pieper B, Kirsner RS. The effect of ankle range of motion on venous ulcer healing rates. Wound Repair Regen. 2014 Jul-Aug;22(4):492-6. doi: 10.1111/wrr.12186.

  PMID: 25041619 BACKGROUND

• Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

  PMID: 10380242 BACKGROUND

• Rubin RW, Maher M. Actin turnover during encystation in Acanthamoeba. Exp Cell Res. 1976 Nov;103(1):159-68. doi: 10.1016/0014-4827(76)90251-2. No abstract available.

  PMID: 991946 BACKGROUND

• Da Matta, E.S. et al. A Combined Therapy Protocol to Improve Lower Extremity Muscle Pumping Function and Lymphatic Drainage for Venous Ulcer Healing. J Vasc Med Surg. 2017;5:347. Doi: 10.4172/2329-6925.1000347

  BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eduardo Matta, MD

  Pró Circulação®

  PRINCIPAL INVESTIGATOR

• Clodoaldo A. De Sá, Ph.D.

  Unochapecó

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 26, 2021
• Study Start: May 3, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)