Protocol summary

Summary
The purpose of present trial is to investigate the effect of exercise therapy on osteoporosis. 90 postmenopausal osteoporotic women referred to the physical medicine and rehabilitation clinic are randomized into three groups of 30 people. Then, drug therapy; including alendronate, calcium, and vitamin D is begun in all three groups. In the second and third groups, different exercises are also applied in addition to medication. In the second group, aerobic exercise, including walking on the treadmill and stationary cycling, and in the third group isotonic and isometric strengthening exercises of trunk and hip and knee muscles, are conducted for 9 months with three months relative resting phase.In other words our sports therapy program was over ally included six month exercise accompany with three month home-based exercises within therapy periods. Before treatment, quadriceps muscles strength, hip abductors and extensors of trunk are determined by MMT. To measure the balance status, fall risk and postural stability indices are determined using Biodex balance training instrument. Bone density of lumbar and femoral neck areas are measured by DEXA method and T-score is determined. Finally, SF36 questionnaire of "quality of life" is completed by the patients. The above-mentioned check-ups will be repeated and compared again after 6 months in all three groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008153217N2
Registration date: 2010-09-14, 1389/06/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-09-14, 1389/06/23
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Aerobic and Strengthening Exercises on Balance, Muscle Strength and Bone Density among the Post Menopausal Women with Osteopenia and Osteoporosis
Public title
Exercise therapy on osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:post menopausal women with severe osteopenia and osteoporosis (T-score<-2.5). Exclusion Criteria : presence of severe cardiovascular disease, severe joint degenerative diseases or severe musculoskeletal disorders and performing physical activities other than our prescribed exercise programs.
Age
From 47 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Chancellor of Tabriz University of Medical Sciences
Street address
Research Chancellor-3rd floor-Central building number 2-Tabriz University of Medical Sciences-Golgasht Avenue-Tabriz
City
Tabriz
Postal code
51656
Approval date
2009-03-29, 1388/01/09
Ethics committee reference number
141/4/5

Health conditions studied

1

Description of health condition studied
Post menopausal osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Post menopausal osteoporosis without fracture

Primary outcomes

1

Description
Bone Mineral Density (BMD)
Timepoint
before intervention and 6 months after intervention (immidiately after termination of treatment)
Method of measurement
using Dual Energy X-ray Absorbtiometry (DEXA) with measurment of T-score

2

Description
Time up & go (TUG)
Timepoint
before intervention and 6 months after intervention (immidiately after termination of treatment)
Method of measurement
using chronometer this six meter distance is measured by seconds.

3

Description
Fall risk
Timepoint
before intervention and 6 months after intervention (immidiately after termination of treatment)
Method of measurement
using Biodex balance training is measured and because it is a relative value,it has not special unit.

4

Description
Postural Stability
Timepoint
before intervention and 6 months after intervention (immidiately after termination of treatment)
Method of measurement
using Biodex balance training is measured and because it is a relative value,it has not special unit.

5

Description
Muscle Strength
Timepoint
before intervention and 6 months after intervention (immidiately after termination of treatment)
Method of measurement
It is evaluated via manual muscle testing(MMT) in physical examination.This relative indicator is measured between 1/5 to 5/5.

Secondary outcomes

1

Description
Quality of life
Timepoint
before intervention and 6 months after intervention (Immediately after treatment)
Method of measurement
This variable is measured using SF36 Questionnaire with scoring between 0 to 100.

2

Description
Body Mass Index (BMI)
Timepoint
before intervention and 6 months after intervention (Immediately after treatment)
Method of measurement
BMI is measured by body composition test instrumentation and its unit is Kg/m2.

Intervention groups

1

Description
Drug therapy, including alendronate, calcium and vitamin D in control groups
Category
Treatment - Drugs

2

Description
Drug therapy, including alendronate, calcium and vitamin D as well as Aerobic exercises including three steps;warm up for 10 minutes,walking on treadmill with 60-80% of maximum heart rate and stationary cycling for 30 minutes and finally cooling down for 5 minutes following by relaxation and stretching exercises are performing.Each interventional group is including 10-15 patients and these exercises are conducted for 6 months with one month resting.
Category
Rehabilitation

3

Description
Drug therapy, including alendronate, calcium and vitamin D as well as Strengthening exercises for trunk extensors,hip abductors and knee extensors or quadriceps muscles initially Isometric and then Isotonic; against resistence are performing.Each interventional group is including 10-15 patients and these exercises are conducted for 6 months with one month resting phase.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Educational and Treatment center
Full name of responsible person
Maryam Ariajoo
Street address
Physical Medicine & Rehabilitation Ward, Shahid Madani Hospital, Daneshgah Ave.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Azam Safi
Street address
Research Chancellor-3rd floor-Central building number 2-Tabriz University of Medical Sciences-Golgasht Avenue-Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Chancellor of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jalil Toofan
Position
Physician, Resident of Physcial medicie and Rehabiliation
Other areas of specialty/work
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
Email
jtoofan_1974@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamian
Position
Assistant professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
+98 41 1337 3967
Email
eslamiyanf@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamian
Position
Assistant professor of physical medicine & Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine & Rehabilitation ward, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
Email
eslamiyanf@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...