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

Osteoporosis Clinical Trial

Official title:

Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210469
• Other study ID #: 787/06
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: October 5, 2010
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: March 2008
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Strengthening and balance exercises
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
• Stretching and balance exercises
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural Control	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	eight weeks	Yes
Secondary	Postural alignment	Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)	eight weeks	Yes
Secondary	Lower limb muscle strength	The muscle strength in knee extension and knee flexion was evaluated by dynamometry.	eight weeks	Yes
Secondary	Shortening of the hamstrings	The shortening of the hamstrings was evaluated by goniometry.	eight weeks	Yes
Secondary	Berg Balance Scale		Eight weeks	Yes

External Links

•   Link to my thesis in portuguese