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Motor Control Exercise in Osteoporotic Women

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Motor control exercise
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Pain, Kyphosis, Posture, Exercise therapy

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Postmenopausal osteoporosis
  • Osteoporotic vertebral fractures
  • Pain
  • Under medical osteoporotic treatment

Exclusion Criteria:

  • osteoporosis other than primary postmenopausal
  • vertebral collapse with neurological deficits
  • more than 5 fractured vertebrae
  • major respiratory conditions
  • receiving pain reducing agents, teriparatide or calcitonin

Sites / Locations

  • Hospital Thias Pronoias 'I Pammakaristos'

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motor control exercise

Control group

Arm Description

Subjects of the exercise group underwent a 3-month (13-week) treatment program directed on 3-weekly 1-hr one-to-one sessions by the researcher who had experience in the specific exercise treatment of the spinal region. During the next 3 months, the subjects were urged to perform the exercises alone at home at least once a day, and compliance was monitored by the activity quota chart given to them at the beginning of each study-month.

The control group underwent treatment throughout a 6-month period, directed by each patient's medical practitioner. This consisted of the patients carrying out regular weekly general exercises (walking and swimming). Three of them regularly attended other treatment providers involving group general exercise programs. Two patients received the application of local pain-relieving methods such as heat, massage, laser and ultrasound and one did nothing except for receiving osteoporotic medication.

Outcomes

Primary Outcome Measures

Pain
Pain was assessed using the visual analogue scale (VAS) of 11 numerical points (0='no pain', 10='worst imaginable pain'). Participants were asked to verbalize the presence of pain in their trunk and lower limbs during the previous 2 weeks.
Pain
As described
Pain
As described

Secondary Outcome Measures

Photographic measurements
Two-dimensional posture photography was performed using a digital Video Camera. With participants in their underwear, self-adhesive patches of 1.5 cm were placed over the left-side lateral landmarks. Women were instructed to stand in a comfortable posture with feet 20 cm apart. The participants were photographed twice at each time point. The photographs were analyzed by measuring the angles between a perpendicular line transcending the lateral malleolus, head of fibula, great trochanter, shoulder and ear. The mean of each angle of both photographs was used for statistical analysis.
Spinal curvatures
These were measured using a Sounders digital inclinometer according to the instruction manual. Standing thoracic, lumbar, and lumbosacral angle were measured. The examiner repeated the procedure three times, and if the measurements differed by more than 5 degrees, they were repeated and the second set of measurements recorded.
Photographic measurements
As described
Spinal curvatures
As described
Photographic measurements
As described
Spinal curvatures
As described

Full Information

First Posted
July 28, 2010
Last Updated
July 29, 2010
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01172574
Brief Title
Motor Control Exercise in Osteoporotic Women
Official Title
Motor Control Exercise Can Reduce Pain and Improve Postural Alignment in Osteoporotic Women With Vertebral Fractures: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to explore the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fractures.
Detailed Description
Osteoporosis is a common metabolic bone disease that usually affects the aging population. It is an important public health problem, due to its association with vertebral and nonvertebral fractures leading to increased morbidity. Vertebral fractures are accompanied by kyphosis, reduced pulmonary function, loss of height, and are often associated with elevated pain while they may also lead to subsequent vertebral fractures. Osteoporotic individuals exhibit kyphosis in the erect standing position, which, in turn, is compensated by the deformation of other parts of the body. Improvement of postural alignment may lead to less stress on the spine, facilitate posture and proper body mechanics and may improve balance. The aim of the present study was to assess the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fracture against the results of a control group that received the basic therapies for osteoporosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
Keywords
Osteoporosis, Pain, Kyphosis, Posture, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor control exercise
Arm Type
Experimental
Arm Description
Subjects of the exercise group underwent a 3-month (13-week) treatment program directed on 3-weekly 1-hr one-to-one sessions by the researcher who had experience in the specific exercise treatment of the spinal region. During the next 3 months, the subjects were urged to perform the exercises alone at home at least once a day, and compliance was monitored by the activity quota chart given to them at the beginning of each study-month.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group underwent treatment throughout a 6-month period, directed by each patient's medical practitioner. This consisted of the patients carrying out regular weekly general exercises (walking and swimming). Three of them regularly attended other treatment providers involving group general exercise programs. Two patients received the application of local pain-relieving methods such as heat, massage, laser and ultrasound and one did nothing except for receiving osteoporotic medication.
Intervention Type
Other
Intervention Name(s)
Motor control exercise
Intervention Description
Participants of the exercise group were trained to consciously co-activate the transversus abdominis, pelvic floor and thoracic erector spinae muscle, relax the lumbar multifidus and use the diaphragmatic breathing pattern. They were encouraged to activate the specific muscles of the trunk regularly during daily activities, particularly in situations where they anticipated or experienced pain such as walking, twisting, lifting low-lying objects and working with the hands in sitting or standing positions
Primary Outcome Measure Information:
Title
Pain
Description
Pain was assessed using the visual analogue scale (VAS) of 11 numerical points (0='no pain', 10='worst imaginable pain'). Participants were asked to verbalize the presence of pain in their trunk and lower limbs during the previous 2 weeks.
Time Frame
Baseline
Title
Pain
Description
As described
Time Frame
3 months
Title
Pain
Description
As described
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Photographic measurements
Description
Two-dimensional posture photography was performed using a digital Video Camera. With participants in their underwear, self-adhesive patches of 1.5 cm were placed over the left-side lateral landmarks. Women were instructed to stand in a comfortable posture with feet 20 cm apart. The participants were photographed twice at each time point. The photographs were analyzed by measuring the angles between a perpendicular line transcending the lateral malleolus, head of fibula, great trochanter, shoulder and ear. The mean of each angle of both photographs was used for statistical analysis.
Time Frame
Baseline
Title
Spinal curvatures
Description
These were measured using a Sounders digital inclinometer according to the instruction manual. Standing thoracic, lumbar, and lumbosacral angle were measured. The examiner repeated the procedure three times, and if the measurements differed by more than 5 degrees, they were repeated and the second set of measurements recorded.
Time Frame
Baseline
Title
Photographic measurements
Description
As described
Time Frame
3 months
Title
Spinal curvatures
Description
As described
Time Frame
3 months
Title
Photographic measurements
Description
As described
Time Frame
6 months
Title
Spinal curvatures
Description
As described
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal osteoporosis Osteoporotic vertebral fractures Pain Under medical osteoporotic treatment Exclusion Criteria: osteoporosis other than primary postmenopausal vertebral collapse with neurological deficits more than 5 fractured vertebrae major respiratory conditions receiving pain reducing agents, teriparatide or calcitonin
Facility Information:
Facility Name
Hospital Thias Pronoias 'I Pammakaristos'
City
Athens
State/Province
Attica
ZIP/Postal Code
11144
Country
Greece

12. IPD Sharing Statement

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Motor Control Exercise in Osteoporotic Women

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