Muscle, Ligament and Fascia DisordersNCT01553396
Muscle Strength and Functional Autonomy of Elderly Women
An observational study of Muscle, Ligament and Fascia Disorders, run by Euro-American Network of Human Kinetics.
Trial summary
This study shows an evaluation of the correlation between the muscle strength levels and functional autonomy of elderly women. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Muscle, Ligament and Fascia Disorders
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2009
- Phase
- Observational
- 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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The population consists of 123 elderly women residents of São Lucas shelter, located in Cacimba Velha, Teresina-PI, Brazil. The sample consists of 35 elderly women. The elderly participants in the study signed a written informed consent.
Who may be able to join
- present a muscle-skeletal dysfunction, such as osteoporosis, arthritis, tendinitis, but being able to perform their ADL without help from others;
- did not practice physical activity for at least 12 months;
- provide a normal IGF-1 level for their age;
Who cannot join
- elderly women unfit to perform the strength and functional autonomy tests for the medical assessment;
About this study
Official title: Muscle Strength and Functional Autonomy of Normo-IGF-1 Elderly Women With Skeletal Muscle Dysfunctions
This study shows an evaluation of the correlation between the muscle strength levels and functional autonomy of elderly women.
Read the detailed description
The aim of this study was to evaluate the correlation between the muscle strength levels and functional autonomy of elderly women with impaired muscle-skeletal system depending on the normal IGF-1 level. The target-population was composed by elderly women aged between 60 and 75 years (age: 67.79 ± 5.11 years, BMI: 28.01 ± 5.4), residents of an asylum, with IGF-1 levels within the normal values for the age (normo-IGF-1). Evaluations of the muscle strength (1-RM test) and the functional autonomy (GDLAM Protocol) in the performance of activities of daily living (ADL), and a measurement of basal serum levels of IGF-1 (Chemiluminescence method) were performed.
- Conditions
- Muscle, Ligament and Fascia Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle, Ligament and Fascia DisordersStudies 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
- Observational
- Observational model
- Case only
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Euro-American Network of Human Kinetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estélio HM Dantas, DSc, Study chair, University Castelo Branco (Rio de Janeiro, Brazil)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553396
- Sponsor's protocol ID
- 0165/2008
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength and Functional Autonomy of Normo-IGF-1 Elderly Women With Skeletal Muscle Dysfunctions
- ClinicalTrials.gov ID
- NCT01553396
- Acronym / sponsor ID
- 0165/2008
- Conditions
- Muscle, Ligament and Fascia Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Euro-American Network of Human KineticsUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Mar 2012 (estimated)
- 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.
This study shows an evaluation of the correlation between the muscle strength levels and functional autonomy of elderly women.
Detailed description
The aim of this study was to evaluate the correlation between the muscle strength levels and functional autonomy of elderly women with impaired muscle-skeletal system depending on the normal IGF-1 level. The target-population was composed by elderly women aged between 60 and 75 years (age: 67.79 ± 5.11 years, BMI: 28.01 ± 5.4), residents of an asylum, with IGF-1 levels within the normal values for the age (normo-IGF-1). Evaluations of the muscle strength (1-RM test) and the functional autonomy (GDLAM Protocol) in the performance of activities of daily living (ADL), and a measurement of basal serum levels of IGF-1 (Chemiluminescence method) were performed.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of 123 elderly women residents of São Lucas shelter, located in Cacimba Velha, Teresina-PI, Brazil. The sample consists of 35 elderly women. The elderly participants in the study signed a written informed consent.
Key inclusion criteria (3 listed)
- present a muscle-skeletal dysfunction, such as osteoporosis, arthritis, tendinitis, but being able to perform their ADL without help from others;
- did not practice physical activity for at least 12 months;
- provide a normal IGF-1 level for their age;
Key exclusion criteria (1 listed)
- elderly women unfit to perform the strength and functional autonomy tests for the medical assessment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Mar 2012.
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.
Estélio HM Dantas, DSc study chair
University Castelo Branco (Rio de Janeiro, Brazil)
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle, Ligament and Fascia Disorders, run by Euro-American Network of Human Kinetics.
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 3 inclusion and 1 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 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 14 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.