NCT02968030

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

December 28, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

November 16, 2016

Last Update Submit

December 27, 2016

Conditions

Keywords

AgedPostural balanceMuscle strength

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Muscle strength

    The results were obtained at the end of the eight weeks of intervention

Study Arms (1)

Muscle strength

EXPERIMENTAL

Evaluate the effects of a eight weeks program of strengthening exercise on balance and functional mobility in irregular active elderly women

Other: Muscle strength

Interventions

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.

Also known as: Resistance Training, Strength Training
Muscle strength

Eligibility Criteria

Age61 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 61 and 80
  • irregularly active (IPAQ)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lislei Jorge Patrizzi

Uberaba, Minas Gerais, 38022200, Brazil

Location

MeSH Terms

Interventions

Muscle StrengthResistance Training

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovement

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

December 1, 2009

Last Updated

December 28, 2016

Record last verified: 2016-10

Locations