Multicomponent Intervention in Women at Risk of Sarcopenia

September 15, 2023 updated by: Maria Claudia Espinel Bermudez, Coordinación de Investigación en Salud, Mexico

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Maria Claudia Espinel-Bermudez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multicomponent Intervention in only one group of women at Risk of Sarcopenia
Quasi-experimental Pre-test/Post-test design - pilot
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle mass index (SMI)
Time Frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
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
Grip strength
Time Frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
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
Gait speed
Time Frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measurements
Time Frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polypharmacy report (yes/no)
Time Frame: Baseline measurement
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
Comorbidity
Time Frame: Baseline measurement
Obtained direct information of women about diseases assessed using the Charlson index.
Baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Actual)

September 27, 2019

Study Completion (Actual)

September 27, 2019

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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