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AgingNCT01558401

Efficiency of Physical Activity on the Physical Condition of Elderly Women

A study testing Physical activity program in people with Aging, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Physical activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBrazil
Study dates
Apr 2010to May 2011
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 60 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 60 or more years
  • participants of an Adult Revitalization Program in São Carlos (São Paulo State - Brazil)

Who cannot join

  • physical characteristics and previous health problems that might hinder their participation in the program activities.
  • adherence to the program sessions lower than 75%.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal de Sao Carlos

    São Carlos, São Paulo, 13.565-905

Other trials in Brazil

About this study

Official title: Effects of an Adapted Physical Activity Program on the Physical Condition of Elderly Women: an Analysis of Efficiency

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.

Read the detailed 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.

Conditions
Aging
Being tested
Physical activity program
Keywords
physical activity, elderly, women, efficiency
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity programOther

    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.

Study groups in NCT01558401
Study groupRoleWhat they receive
Physical activity program GroupExperimentalThe physical activity program consists of 123 sessions over 52 weeks. The initial assessment is followed by 12 weeks of physical activity. After this ten-week period, a second assessment is performed, followed by 3 weeks of rest. This is followed by a further 17 weeks of activities, 4 weeks of activities followed by 4 weeks of rest. Finally, there were 12 more weeks of activities.
Receives: Other: Physical activity program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (5)

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. VO2max

    The Rockport 1-Mile Walk Test was used to determine the subjects' physical condition estimated by the VO2max

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2012 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2011
  4. Study completionMay 2011

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558401
Sponsor's protocol ID
Ethics Committe UFSCar Nº104/4
Status last verified
Mar 2012
First submitted
14 Mar 2012
Last updated
20 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19370674

  • 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. doi: 10.1046/j.1532-5415.2003.51365.x.

    PubMed 12890083

  • Laine J, Finne-Soveri UH, Bjorkgren M, Linna M, Noro A, Hakkinen 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. doi: 10.1093/intqhc/mzi032. Epub 2005 Mar 23.

    PubMed 15788463

  • Greve P, Wanderley FDS, 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):268-271. doi: 10.1016/j.archger.2008.09.009. Epub 2008 Nov 6.

    PubMed 18992949

  • Vogel T, Brechat PH, Lepretre 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.

    PubMed 19196369

  • Alburquerque-Sendin F, Barberio-Mariano E, Brandao-Santana N, Rebelatto DA, Rebelatto JR. Effects of an adapted physical activity program on the physical condition of elderly women: an analysis of efficiency. Rev Bras Fisioter. 2012 Jul-Aug;16(4):328-36. doi: 10.1590/s1413-35552012005000025. Epub 2012 Jun 14.

    PubMed 22699693

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity program in people with Aging, run by Universidade Federal de Sao Carlos 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 2 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 20 Mar 2012. 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?

Efficiency Data Envelopment Analysis (DEA) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01558401, which also lists 6 linked publications.

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 20 Mar 2012.

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