AgedNCT02968030
Strengthening in Functional Mobility of Active Elderly
A study testing Muscle strength in people with Aged and Muscle Strength, run by Lislei Jorge Patrizzi at 1 site in Brazil.
Trial summary
Aging is characterized by functional losses among which, the related to mobility and balance may be highlighted. Regular physical activity, including muscle strengthening exercises, is beneficial to a healthy elderly. Read more about this study
- Who is it for?
- Ages 61 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aged, Muscle Strength
- What is being tested?
- Muscle strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2009
- 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 61 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 61 and 80
- irregularly active (IPAQ)
Who cannot join
- Presence of one or more of the following conditions: neurological diseases, impaired cognitive autonomy or limited self-determination capacity, limiting orthopedic injury, orthoses for lower limb, hip or knee prosthesis, the cardiorespiratory system diseases or any kind of commitment that prevented the permanence in the standing position.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Strengthening Exercise Program for Lower Limbs in Functional Mobility From Irregularly Active Elderly
Aging is characterized by functional losses among which, the related to mobility and balance may be highlighted. Regular physical activity, including muscle strengthening exercises, is beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8 weeks-program of lower limbs strengthening exercises in the balance and functional mobility of physically active elderly. The investigators evaluated 18 women, with ages between 61 and 80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of the lower limbs, the workload was determined by the strength reached in the eight-repetition maximum test (8RM), applying progressive load increments between training sessions conducted (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of training, with subsequent adjustment of the load for the subsequent training. The training took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated elderly women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035) and statistically significant increase in muscle strength were observed in all muscle groups trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not significantly different after training. Therefore, strength training proposed was efficient in improving muscle strength in the lower limbs of irregular physically active elderly, impacting positively on functional gain gait. However, the gain in muscle strength was not enough to generate significant results in static balance probably due to the type of exercise performed as well as due being limited to muscle groups of the lower limbs.
- Conditions
- Aged, Muscle Strength
- Being tested
- Muscle strength
- Keywords
- Aged, Postural balance, Muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strengthOther
Also called Resistance Training, Strength Training
Strength training The strength training for lower limbs muscles occurred twice a week, 40 minutes per session for eight consecutive weeks.
n the first two weeks of training, each elderly performed the exercises with 50% of its load defined in 8RM test, increasing to 60 and 70% of the load in the third and fourth subsequent weeks, respectively. After this period, a new evaluation by 8RM strength test was conducted, adopting the fifth and sixth weeks of training 50% of value of the new load defined in 8RM test and to finalize the program in seventh and eighth weeks applied, respectively, 60% and 70% of the new charge. The exercises were performed for the quadriceps, hamstrings, muscles adductor and abductor hip.
| Study group | Role | What they receive |
|---|---|---|
| Muscle strength | Experimental | Evaluate the effects of a eight weeks program of strengthening exercise on balance and functional mobility in irregular active elderly women Receives: Other: Muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility
The TUG allows a quantitative assessment of gait and mobility, enabling the investigation of the effects of a particular intervention on these parameters (Van Iersel et al., 2008). The TUG is a sensitive test, is a good option of choice to be used as the primary outcome measure in clinical trials to improve gait and mobility (Van Iersel et al., 2008). It allows the researcher to observe the sitting balance of transfers from sitting to standing position and vice versa, as well as stability while walking and walking course changes.
For the application of TUG has asked the elderly up from a chair without armrest from the recumbent position, wander around a distance of 3 meters safely and quickly, turn, return on the same route and the chair again with the back supported on back. Performance was assessed by timing the time required for the completion of the test. The time taken for the test is determining the risk for falls, classified as low, when the time spent on the test is less than
Measured: The results were obtained at the end of the eight weeks of intervention
Risk of falls and Balance
To the risk of falls in the elderly, the Romberg test is an effective method, since its completion provides anteroposterior instability or increased body sway. For this test, in the standing position the participants remained with the feet together, aligned head and arms along the body. Then, it was requested that, keeping the position described, the participants close their eyes for a period of 30 seconds. Later, the same test was repeated, but on shaky ground when the participant was left standing position on a foam surface, requesting again the closing of the eyes. A procedure again observing the imbalance with time record in seconds, before its occurrence.
Measured: The results were obtained at the end of the eight weeks of intervention
Secondary outcomes (1)
Muscle strength
To evaluate muscle strength and determination of the optimal load training to strengthen the lower limbs the investigators used the strength test eight maximum repetitions (8RM) for each proposed exercise. The 8RM test corresponded to the maximum load that could be raised by the participants throughout the normal range of motion, maintaining the proper technique in eight repetitions (Canuto et al., 2011). Before starting the test was performed 8RM heating with 10 repetitions without any charge to the motion that would run the test and after two minutes the test was started. The materials used were shinguards 0.5 kg to 5 kg.
Measured: The results were obtained at the end of the eight 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 posted18 Nov 2016 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lislei Jorge Patrizzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lislei Jorge Patrizzi, Universidade Federal do Triangulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968030
- Sponsor's protocol ID
- CEP UFTM 1480
- Status last verified
- Oct 2016
- First submitted
- 16 Nov 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Strengthening Exercise Program for Lower Limbs in Functional Mobility From Irregularly Active Elderly
- ClinicalTrials.gov ID
- NCT02968030
- Acronym / sponsor ID
- CEP UFTM 1480
- Conditions
- Aged, Muscle Strength
- Keywords
- Aged, Postural balance, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lislei Jorge PatrizziUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Nov 2016 (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.
Aging is characterized by functional losses among which, the related to mobility and balance may be highlighted. Regular physical activity, including muscle strengthening exercises, is beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8 weeks-program of lower limbs strengthening exercises in the balance and functional mobility of physically active elderly. The investigators evaluated 18 women, with ages between 61 and 80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of the lower limbs, the workload was determined by the strength reached in the eight-repetition maximum test (8RM), applying progressive load increments between training sessions conducted (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of training, with subsequent adjustment of the load for the subsequent training. The training took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated elderly women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035) and statistically significant increase in muscle strength were observed in all muscle groups trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not significantly different after training. Therefore, strength training proposed was efficient in improving muscle strength in the lower limbs of irregular physically active elderly, impacting positively on functional gain gait. However, the gain in muscle strength was not enough to generate significant results in static balance probably due to the type of exercise performed as well as due being limited to muscle groups of the lower limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle strength | Experimental | Other: Muscle strengthEvaluate the effects of a eight weeks program of strengthening exercise on balance and functional mobility in irregular active elderly women |
Who may qualify
- Ages
- 61 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 61 and 80
- irregularly active (IPAQ)
Key exclusion criteria (1 listed)
- Presence of one or more of the following conditions: neurological diseases, impaired cognitive autonomy or limited self-determination capacity, limiting orthopedic injury, orthoses for lower limb, hip or knee prosthesis, the cardiorespiratory system diseases or any kind of commitment that prevented the permanence in the standing position.
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 |
|---|---|---|
| Muscle strengthAlso: Resistance Training, Strength TrainingStrength training The strength training for lower limbs muscles occurred twice a week, 40 minutes per session for eight consecutive weeks. n the first two weeks of training, each elderly performed the exercises with 50% of its load defined in 8RM test, increasing to 60 and 70% of the load in the third and fourth subsequent weeks, respectively. After this period, a new evaluation by 8RM strength test was conducted, adopting the fifth and sixth weeks of training 50% of value of the new load defined in 8RM test and to finalize the program in seventh and eighth weeks applied, respectively, 60% and 70% of the new charge. The exercises were performed for the quadriceps, hamstrings, muscles adductor and abductor hip. | Other | Muscle strength |
Primary outcome
Functional mobility
Time frame: The results were obtained at the end of the eight weeks of intervention
The TUG allows a quantitative assessment of gait and mobility, enabling the investigation of the effects of a particular intervention on these parameters (Van Iersel et al., 2008). The TUG is a sensitive test, is a good option of choice to be used as the primary outcome measure in clinical trials to improve gait and mobility (Van Iersel et al., 2008). It allows the researcher to observe the sitting balance of transfers from sitting to standing position and vice versa, as well as stability while walking and walking course changes. For the application of TUG has asked the elderly up from a chair without armrest from the recumbent position, wander around a distance of 3 meters safely and quickly, turn, return on the same route and the chair again with the back supported on back. Performance was assessed by timing the time required for the completion of the test. The time taken for the test is determining the risk for falls, classified as low, when the time spent on the test is less than
Risk of falls and Balance
Time frame: The results were obtained at the end of the eight weeks of intervention
To the risk of falls in the elderly, the Romberg test is an effective method, since its completion provides anteroposterior instability or increased body sway. For this test, in the standing position the participants remained with the feet together, aligned head and arms along the body. Then, it was requested that, keeping the position described, the participants close their eyes for a period of 30 seconds. Later, the same test was repeated, but on shaky ground when the participant was left standing position on a foam surface, requesting again the closing of the eyes. A procedure again observing the imbalance with time record in seconds, before its occurrence.
1 secondary outcome
Muscle strength
Time frame: The results were obtained at the end of the eight 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 28 Dec 2016.
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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 Muscle strength in people with Aged and Muscle Strength, run by Lislei Jorge Patrizzi at 1 site in Brazil.
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 2 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 28 Dec 2016. 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 Brazil. 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?
Functional mobility (time frame: The results were obtained at the end of the eight weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 28 Dec 2016.