Multicomponent Intervention in Women at Risk of Sarcopenia

Sponsor
Coordinación de Investigación en Salud, Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT06038500
Collaborator
University of Guadalajara (Other), Universidad de Colima (Other)
14
1
1
3.8
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multicomponent intervention of resistance exercises, dancing sessions and nutritional education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
quasi-experimental Pre-test/Post-test design - pilotquasi-experimental Pre-test/Post-test design - pilot
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of an Intervention of Dance, Resistance Exercises and Nutritional Recommendations on Muscle Mass and Strength in Women With Risk of Sarcopenia
Actual Study Start Date :
Jun 3, 2019
Actual Primary Completion Date :
Sep 27, 2019
Actual Study Completion Date :
Sep 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multicomponent Intervention in only one group of women at Risk of Sarcopenia

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

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.

Outcome Measures

Primary Outcome Measures

  1. Grip strength [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).

  2. Skeletal muscle mass index (SMI) [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)

  3. Gait speed [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).

Secondary Outcome Measures

  1. Anthropometric measurements [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).

Other Outcome Measures

  1. Polypharmacy report (yes/no) [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.

  2. Comorbidity [Baseline measurement]

    Obtained direct information of women about diseases assessed using the Charlson index.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maria Claudia Espinel-Bermudez Guadalajara Jalisco Mexico 44340

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Claudia Espinel Bermudez, Principal Investigator, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT06038500
Other Study ID Numbers:
  • R-2019-1310-040
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Claudia Espinel Bermudez, Principal Investigator, Coordinación de Investigación en Salud, Mexico
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023