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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968030
Other study ID # CEP UFTM 1480
Secondary ID
Status Completed
Phase N/A
First received November 16, 2016
Last updated December 27, 2016
Start date January 2008
Est. completion date December 2009

Study information

Verified date October 2016
Source Universidade Federal do Triangulo Mineiro
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 2009
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 61 Years to 80 Years
Eligibility Inclusion Criteria:

- aged between 61 and 80

- irregularly active (IPAQ)

Exclusion Criteria:

- 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Muscle strength
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.

Locations

Country Name City State
Brazil Lislei Jorge Patrizzi Uberaba Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Lislei Jorge Patrizzi

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
The results were obtained at the end of the eight weeks of intervention Yes
Primary 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. The results were obtained at the end of the eight weeks of intervention Yes
Secondary 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. The results were obtained at the end of the eight weeks of intervention Yes
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