Multicomponent Intervention in Women at Risk of Sarcopenia

Sarcopenia Clinical Trial

Official title:

Effect of an Intervention of Dance, Resistance Exercises and Nutritional Recommendations on Muscle Mass and Strength in Women With Risk of Sarcopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06038500
• Other study ID #: R-2019-1310-040
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: September 27, 2019

Study information

• Verified date: September 2023
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Physical exercise, especially resistance exercise, is one of the best non-pharmacological treatment alternatives due to its multiple health benefits and could be a promoter for the prevention of sarcopenia by delaying muscle atrophy produced by the natural aging process. However, scientific literature shows that this activity when combined with other strategies has a better effect on sarcopenia indicators than alone. Dance is a social activity that is part of the culture and life history of human beings, however, current research has focused on studying the cognitive and visuospatial effects of this activity. It could be an activity with beneficial effects on the physical abilities of the individual since dancing improves flexibility, resistance and balance. However, the study of these two strategies, along with nutritional education has been little studied.

Therefore, a pilot test was proposed with the aim of knowing the possible effect of a multicomponent intervention on muscle, strength, performance, and body composition on women at risk of sarcopenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Body Composition
• Grip Strength
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Mexico	Maria Claudia Espinel-Bermudez	Guadalajara	Jalisco

Sponsors (3)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Universidad de Colima, University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Polypharmacy report (yes/no)	Obtained direct information of women about current pharmacological regimens for diseases. Polypharmacy was defined as the use of five or more medications according to what was established by Integrated care for older people (ICOPE) of the WHO.	Baseline measurement
Other	Comorbidity	Obtained direct information of women about diseases assessed using the Charlson index.	Baseline measurement
Primary	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
Primary	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
Primary	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	Anthropometric measurements	Height, mid-arm, waist, hip, and calf measurements stipulated by the ISAK protocol, all measurements were quantified in centimeters (cm).	Baseline measurement and final measurement as the end of the 12 weeks of intervention