Clinical trial NCT05023642: Training-induced Muscle Strength and Its Role in Interface Pressure in Inelastic Compression
Official title: Training-induced Muscle Strength Increase and Its Role in Interface Pressure in Inelastic Compression: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Keywords: Inelastic compression
Resistance exercise
Muscle hypertrophy
Chronic venous disease
Lead sponsor: Pró Circulação®
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline body composition at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline muscle strength at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline handgrip strength at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline walking speed at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline interface pressure at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline Static Stiffness Index at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline Working Pressure Amplitude at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
Secondary outcomes:
measure: Change from quality of life assessment at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline lower limbs' functional strength at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
measure: Change from baseline dynamic balance at 12 weeks
timeFrame: Baseline visit and follow-up after 12 weeks
Other outcomes:
Locations:
city: Chapecó
country: Brazil
facility: Unochapecó University
state: Santa Catarina
city: Xanxerê
country: Brazil
facility: Pró Circulação® - Clinic of Angiology and Vascular Surgery
state: Santa Catarina
Study officials:
affiliation: Pró Circulação®
name: Eduardo Matta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unochapecó
name: Clodoaldo A. De Sá, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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