SarcopeniaNCT06038500
Multicomponent Intervention in Women at Risk of Sarcopenia
A study testing Multicomponent intervention of resistance exercises, dancing sessions and nutritional education in people with Sarcopenia and Grip Strength, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Sarcopenia, Grip Strength, Gait Speed
- What is being tested?
- Multicomponent intervention of resistance exercises, dancing sessions and nutritional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- 3 Jun 2019to 27 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia, Grip Strength, Gait Speed, Body Composition
- Being tested
- Multicomponent intervention of resistance exercises, dancing sessions and nutritional education
- Keywords
- Sarcopenia, Multicomponent, Aging, Preventive
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent intervention of resistance exercises, dancing sessions and nutritional educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Intervention in only one group of women at Risk of Sarcopenia | Experimental | Quasi-experimental Pre-test/Post-test design - pilot Receives: Other: Multicomponent intervention of resistance exercises, dancing sessions and nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline measurement and final measurement as the end of the 12 weeks of intervention
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)
Measured: Baseline measurement and final measurement as the end of the 12 weeks of intervention
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).
Measured: Baseline measurement and final measurement as the end of the 12 weeks of intervention
Secondary outcomes (1)
Anthropometric measurements
Height, mid-arm, waist, hip, and calf measurements stipulated by the ISAK protocol, all measurements were quantified in centimeters (cm).
Measured: Baseline measurement and final measurement as the end of the 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start3 Jun 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi-experimental Pre-test/Post-test design - pilot
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- University of Guadalajara, Universidad de Colima
- Responsible party
- Principal investigator, Maria Claudia Espinel Bermudez, Coordinación de Investigación en Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038500
- Sponsor's protocol ID
- R-2019-1310-040
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rios-Escalante V, Perez-Barba JC, Espinel-Bermudez MC, Zavalza-Gomez AB, Arias-Merino ED, Zavala-Cerna MG, Sanchez-Garcia S, Trujillo X, Nava-Zavala AH. Effects of a Multicomponent Preventive Intervention in Women at Risk of Sarcopenia: A Pilot Study. Healthcare (Basel). 2024 Jun 13;12(12):1191. doi: 10.3390/healthcare12121191.
PubMed 38921304
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Intervention of Dance, Resistance Exercises and Nutritional Recommendations on Muscle Mass and Strength in Women With Risk of Sarcopenia
- ClinicalTrials.gov ID
- NCT06038500
- Acronym / sponsor ID
- R-2019-1310-040
- Conditions
- Sarcopenia, Grip Strength, Gait Speed, Body Composition
- Keywords
- Sarcopenia, Multicomponent, Aging, Preventive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- University of Guadalajara, Universidad de Colima
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi-experimental Pre-test/Post-test design - pilot
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Intervention in only one group of women at Risk of Sarcopenia | Experimental | Other: Multicomponent intervention of resistance exercises, dancing sessions and nutritional educationQuasi-experimental Pre-test/Post-test design - pilot |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent intervention of resistance exercises, dancing sessions and nutritional educationThe 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. | Other | Multicomponent Intervention in only one group of women at Risk of Sarcopenia |
Primary outcome
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).
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)
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).
1 secondary outcome
Anthropometric measurements
Time frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 38921304Rios-Escalante V, Perez-Barba JC, Espinel-Bermudez MC, Zavalza-Gomez AB, Arias-Merino ED, Zavala-Cerna MG, Sanchez-Garcia S, Trujillo X, Nava-Zavala AH. Effects of a Multicomponent Preventive Intervention in Women at Risk of Sarcopenia: A Pilot Study. Healthcare (Basel). 2024 Jun 13;12(12):1191. doi: 10.3390/healthcare12121191.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention of resistance exercises, dancing sessions and nutritional education in people with Sarcopenia and Grip Strength, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.