- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06038500
Multicomponent Intervention in Women at Risk of Sarcopenia
Effect of an Intervention of Dance, Resistance Exercises and Nutritional Recommendations on Muscle Mass and Strength in Women With Risk of Sarcopenia
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jalisco
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Guadalajara, Jalisco, Mexico, 44340
- Maria Claudia Espinel-Bermudez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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Experimental: Multicomponent Intervention in only one group of women at Risk of Sarcopenia
Quasi-experimental Pre-test/Post-test design - pilot
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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.
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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)
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Baseline measurement and final measurement as the end of the 12 weeks of intervention
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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).
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Baseline measurement and final measurement as the end of the 12 weeks of intervention
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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).
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Baseline measurement and final measurement as the end of the 12 weeks of intervention
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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).
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Baseline measurement and final measurement as the end of the 12 weeks of intervention
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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.
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Baseline measurement
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Comorbidity
Time Frame: Baseline measurement
|
Obtained direct information of women about diseases assessed using the Charlson index.
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Baseline measurement
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-2019-1310-040
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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