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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01558401
Other study ID # Ethics Committe UFSCar Nº104/4
Secondary ID
Status Completed
Phase N/A
First received March 14, 2012
Last updated March 19, 2012
Start date April 2010
Est. completion date May 2011

Study information

Verified date March 2012
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study was to identify the effects and the efficiency of an adapted physical activity program as regards the physical condition of older Brazilian women.


Description:

Although physical activity programs for the elderly have proved to be able to curb harmful changes due to ageing, not all programs show the same effectiveness, even though they are generally regarded as being effective. The existence of a wide variety of programs calls for debate about their outcomes.

Specific research tools and designs can assist in identifying not only program effectiveness but also program efficiency and use in terms of a better physical performance of subjects on carrying out exercises with less effort, influenced by multiple factors, one of them being adherence to the program. These analyses allow the influence of efficiency and the factors that determine it or are associated with it to be tested, and can provide classifications and subgroups to which interventions should be adapted if they are to offer the best service to them in the short and medium term.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 60 or more years

- participants of an Adult Revitalization Program in São Carlos (São Paulo State - Brazil)

Exclusion Criteria:

- physical characteristics and previous health problems that might hinder their participation in the program activities.

- adherence to the program sessions lower than 75%.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Physical activity program
The activities are done in groups of no more than 25 individuals; these activities are standardized and agreed upon by the research team, which hold monthly meetings to conduct the study. Each physical activity session consists of 8-10 minutes of exercises aimed at stretching the major muscle groups (pectoral muscles, latissimus dorsi, cervical paravertebral, and posterior and anterior thigh muscles); 9 minutes of aerobic endurance activity (march/fast walk); 7-10 minutes of adapted strength exercises, power, and endurance training; 14-16 minutes of coordination, agility, and flexibility exercises, and 5-7 minutes of respiratory and relaxation exercises.

Locations

Country Name City State
Brazil Universidade Federal de Sao Carlos Sao Carlos Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Conn VS, Minor MA, Burks KJ, Rantz MJ, Pomeroy SH. Integrative review of physical activity intervention research with aging adults. J Am Geriatr Soc. 2003 Aug;51(8):1159-68. Review. — View Citation

Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD007146. — View Citation

Greve P, Wanderley Fda S, Rebelatto JR. The effects of periodic interruptions of physical activities on the physical capacities of adult active women. Arch Gerontol Geriatr. 2009 Sep-Oct;49(2):268-71. doi: 10.1016/j.archger.2008.09.009. Epub 2008 Nov 6. — View Citation

Laine J, Finne-Soveri UH, Björkgren M, Linna M, Noro A, Häkkinen U. The association between quality of care and technical efficiency in long-term care. Int J Qual Health Care. 2005 Jun;17(3):259-67. Epub 2005 Mar 23. — View Citation

Vogel T, Brechat PH, Leprêtre PM, Kaltenbach G, Berthel M, Lonsdorfer J. Health benefits of physical activity in older patients: a review. Int J Clin Pract. 2009 Feb;63(2):303-20. doi: 10.1111/j.1742-1241.2008.01957.x. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficiency Data Envelopment Analysis (DEA) Data Envelopment Analysis (DEA) is a test of operational investigation It was used to determine the relative efficiency of the older women, considered Decision Making Units (DMU). This analysis supports the hypothesis that the outputs do not need to be proportional to the inputs. 1 year Yes
Secondary Grip strength Grip strength was measured using a Sammons Preston Swedley-Type hand dynamometer (Jamar® Bolingbrook IL, 60440). The test was performed three times on the dominant upper limb at 10-second intervals between each run. The grip strength assigned to each participant was the highest of the three values measured. Subjects were guided to hold the grip meter during exhalation without performing the Valsalva maneuver; they were encouraged verbally throughout the test. 1 year Yes
Secondary Sit-and-Reach Test The Sit-and-Reach Test was employed to evaluate the participants' flexibility of the posterior trunk and lower limbs. The movement was performed three times. The flexibility assigned to subjects was the highest value measured. 1 year Yes
Secondary Static balance Static balance was verified by the One-Leg Stance Test with eyes open31. The subjects gazed at a fixed point two meters away for no more than 30 seconds, with one leg bent at the knee. The test was done three times with open and closed eyes and for both legs, taking into account for each condition (open or closed eyes) the mean value of the measures. 1 year Yes
Secondary Dynamic balance Dynamic balance was evaluated by the Maximum Gait Velocity (MGV). The subjects were instructed to walk along a 33.3cm-wide and 3.33m-long band painted on the floor in the shortest possible time. The test was performed three times. The dynamic balance value assigned to each subject was the mean time walking along the band. 1 year Yes
Secondary VO2max The Rockport 1-Mile Walk Test was used to determine the subjects' physical condition estimated by the VO2max 1 year Yes
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