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Multicomponent Intervention in Women at Risk of Sarcopenia

Primary Purpose

Sarcopenia, Grip Strength, Gait Speed

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Multicomponent intervention of resistance exercises, dancing sessions and nutritional education
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Multicomponent, Aging, Preventive

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Maria Claudia Espinel-Bermudez

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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)
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).

Secondary Outcome Measures

Anthropometric measurements
Height, mid-arm, waist, hip, and calf measurements stipulated by the ISAK protocol, all measurements were quantified in centimeters (cm).

Full Information

First Posted
September 8, 2023
Last Updated
September 15, 2023
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
University of Guadalajara, Universidad de Colima
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1. Study Identification

Unique Protocol Identification Number
NCT06038500
Brief Title
Multicomponent Intervention in Women at Risk of Sarcopenia
Official Title
Effect of an Intervention of Dance, Resistance Exercises and Nutritional Recommendations on Muscle Mass and Strength in Women With Risk of Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
University of Guadalajara, Universidad de Colima

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Grip Strength, Gait Speed, Body Composition
Keywords
Sarcopenia, Multicomponent, Aging, Preventive

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
quasi-experimental Pre-test/Post-test design - pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent Intervention in only one group of women at Risk of Sarcopenia
Arm Type
Experimental
Arm Description
Quasi-experimental Pre-test/Post-test design - pilot
Intervention Type
Other
Intervention Name(s)
Multicomponent intervention of resistance exercises, dancing sessions and nutritional education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grip strength
Description
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).
Time Frame
Baseline measurement and final measurement as the end of the 12 weeks of intervention
Title
Skeletal muscle mass index (SMI)
Description
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)
Time Frame
Baseline measurement and final measurement as the end of the 12 weeks of intervention
Title
Gait speed
Description
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).
Time Frame
Baseline measurement and final measurement as the end of the 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Anthropometric measurements
Description
Height, mid-arm, waist, hip, and calf measurements stipulated by the ISAK protocol, all measurements were quantified in centimeters (cm).
Time Frame
Baseline measurement and final measurement as the end of the 12 weeks of intervention
Other Pre-specified Outcome Measures:
Title
Polypharmacy report (yes/no)
Description
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.
Time Frame
Baseline measurement
Title
Comorbidity
Description
Obtained direct information of women about diseases assessed using the Charlson index.
Time Frame
Baseline measurement

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Maria Claudia Espinel-Bermudez
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

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Multicomponent Intervention in Women at Risk of Sarcopenia

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