Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01210469
First received: September 27, 2010
Last updated: October 5, 2010
Last verified: March 2008
  Purpose

The purpose of this study was compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.


Condition Intervention
Osteoporosis
Other: Strengthening and balance exercises
Other: Stretching and balance exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Postural Control [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
    Postural control was evaluated by Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate


Secondary Outcome Measures:
  • Postural alignment [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
    Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)

  • Lower limb muscle strength [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
    The muscle strength in knee extension and knee flexion was evaluated by dynamometry.

  • Shortening of the hamstrings [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
    The shortening of the hamstrings was evaluated by goniometry.

  • Berg Balance Scale [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strengthening Group
Performed balance training with lower limbs muscle strengthening.
Other: Strengthening and balance exercises
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Other Names:
  • Force Platform
  • Balance Master
Experimental: Stretching Group
Performed balance training with stretching
Other: Stretching and balance exercises
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Other Names:
  • Force Platform
  • Balance Master
No Intervention: Control Group

Detailed Description:

The decrease in postural control and muscle strength in lower limbs have been identified as major risk factors for falls in older people. Exercises have proven effective in decreasing risk factors in healthy elderly, but little is known about the effects of interventions with exercise in the elderly with osteoporosis.

Objective: To compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.

Methods: Fifty elderly aged 65 or older, with a diagnosis of osteoporosis, were randomized into 3 groups: Strength Group (n = 17) performed balance training with muscle strengthening; Stretching Group (n = 17) performed balance training with stretching; and Control Group (n =16) did not do activity. The groups trained for 8 weeks, with sessions of about 60 minutes, twice a week. Postural control was evaluated by Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate, the functional balance by Berg Balance Scale (BBS), muscle strength by dynamometry, the shortening of the hamstrings by goniometry and posture by PAS/SAPO (Postural Assessment Software).

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women from 65 to 80 yrs of age
  • diagnosis of osteoporosis classified according to the criteria of the World Health Organization, with bone mineral densitometry reduced by at least 2.5 SD when compared with young adults (region of lumbar spine)

Exclusion Criteria:

  • severe visual deficiency
  • physically incapable of participating in the tests
  • neurological disorders, amputations, or prostheses
  • individuals with regular physical activity (twice or more per week) or who had recently participated in exercise programs for muscular strength or balance
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01210469

Locations
Brazil
University of Sao Paulo General Hospital
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Thomaz N Burke, MSc University of São Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Thomaz Nogueira Burke, Ms, University of São Paulo
ClinicalTrials.gov Identifier: NCT01210469     History of Changes
Other Study ID Numbers: 787/06
Study First Received: September 27, 2010
Last Updated: October 5, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
elderly
postural balance
musculoskeletal equilibrium
posture
muscle strength
muscle stretching exercises

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014