Multicomponent Intervention in Women at Risk of Sarcopenia

NCT06038500 | Completed

• 1 other identifier: R-2019-1310-040
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental pilot study is to evaluate the effect of a multi-component intervention in women between 55 and 75 years old at risk of sarcopenia. The main question it aims to answer are: What is the effect of a multi-component intervention in women at risk of sarcopenia? Participants will twelve women between 55 and 75 years old with risk of sarcopenia, who agreed through written informed consent for participate 12 weeks with 24 sessions included dancing, resistance exercises, and nutritional education. The outcomes were muscle mass, grip strength, gait speed and body composition. The effects were measured before and after the intervention, under a self-controlled design.

Conditions

Sarcopenia; Grip Strength; Gait Speed; Body Composition

Keywords

Sarcopenia; Multicomponent; Aging; Preventive

Outcome Measures

Primary Outcomes (3)

• Grip strength

  Evaluated with the JAMAR Plus+ Patterson Medical® digital dynamometer, using the technique proposed by the American Society of Hand Therapists. It was based on the average among all the attempts done on each hand. The results were obtained in kilograms (kg).

  Baseline measurement and final measurement as the end of the 12 weeks of intervention

• Skeletal muscle mass index (SMI)

  Based on the formula validated by Yamada et al (10.3390/ijerph14070809) for multi-frequency devices using the measurements taken with a TANITA MC 780 (ALM = (0.6947 × (Ht\^2/Z50)) + (-55.24 × (Z250/Z5)) + (-10,940 × (1/Z50)) + 51.33)

  Baseline measurement and final measurement as the end of the 12 weeks of intervention

• Gait speed

  Evaluated with a stopwatch to estimate the time after acceleration and before deceleration for a total distance of 4 meters. The unit of measurement was meters between seconds (m/s).

  Baseline measurement and final measurement as the end of the 12 weeks of intervention

Secondary Outcomes (1)

• Anthropometric measurements

  Baseline measurement and final measurement as the end of the 12 weeks of intervention

Other Outcomes (2)

• Polypharmacy report (yes/no)

  Baseline measurement

• Comorbidity

  Baseline measurement

Study Arms (1)

Multicomponent Intervention in only one group of women at Risk of Sarcopenia

EXPERIMENTAL

Quasi-experimental Pre-test/Post-test design - pilot

Other: Multicomponent intervention of resistance exercises, dancing sessions and nutritional education

Interventions

Multicomponent intervention of resistance exercises, dancing sessions and nutritional education OTHER

The intervention consisted of two sets of ten repetitions of resistance exercises, the second month four sets of eight repetitions, and the third month four sets of fifteen repetitions. It was estimated that each session (dance + resistance exercise) generated a caloric expenditure of 270.85 calories corresponding to 4.5 and 3.5 METs per activity. The resistance exercises and the dance sessions began and with a warm-up and stretching session 10 min, followed by the resistance exercises 30 min and dancing practice 30 min. The session ended with a cooling down session 10 min. The nutritional education offered included weekly topics lasting 20 min, on basic concepts of nutrition and recommended diet for the maintenance of skeletal muscle mass. Reinforcement of the topics was carried out through triptychs that were provided throughout the 12 sessions.

Multicomponent Intervention in only one group of women at Risk of Sarcopenia

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive requested through written informed consent
• Current public health insurance
• Preserved physical and mental capacities (verified through data from the medical record)
• Having a lower grip strength, less or equal to 20.99 kg
• Appendicular skeletal muscle index (ASMI) maintained, greater or equal to 5.5 kg/m\^2
• Walking speed greater or equal to 0.8 m/s

You may not qualify if:

• Bioelectric activity add (osteosynthesis metal systems or devices, pacemakers, defibrillators)
• Alterations of body composition (history of cancer, uncontrolled chronic degenerative diseases, risk of malnutrition, respiratory insufficiency, asthma or chronic obstructive pulmonary disease, hospitalization in the year prior to the study; limitations in carrying out the basic activities of daily living; medical contraindication for physical activity, and or belonging to another physical activity group).

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• University of Guadalajara: collaborator
• Universidad de Colima: collaborator

Study Sites (1)

Maria Claudia Espinel-Bermudez

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (1)

• Rios-Escalante V, Perez-Barba JC, Espinel-Bermudez MC, Zavalza-Gomez AB, Arias-Merino ED, Zavala-Cerna MG, Sanchez-Garcia S, Trujillo X, Nava-Zavala AH. Effects of a Multicomponent Preventive Intervention in Women at Risk of Sarcopenia: A Pilot Study. Healthcare (Basel). 2024 Jun 13;12(12):1191. doi: 10.3390/healthcare12121191.

  PMID: 38921304 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: quasi-experimental Pre-test/Post-test design - pilot

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: June 3, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ME (1)