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Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients

Primary Purpose

Burns

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Qigong exercise program
Sponsored by
Eman Mohamed othman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients were 25-50 years old
  • had thermal burn injuries of 2nd-3rd degree extended from the lower area of trunk to the lower extremities.
  • the affected total body surface area of 30-45%.
  • In the early burn stage (30-45 days in burn units), all patients were subjected to a unified physical therapy program consisted of positioning, range of motion, and gentle stretching exercises.

Exclusion Criteria:

  • any history of endocrine, metabolic or other systemic diseases
  • prior or ongoing supplementation with calcium
  • previous or current bone-specific drugs or diseases affecting bone metabolism
  • smoking
  • any neurogenic disorder impairing sensory or motor function
  • use of drugs known to affect the central nervous system or equilibrium
  • previous brain injury or any disease affecting balance
  • history of epilepsy
  • previous or habitual high-intensity exercise
  • lower extremity arthralgia
  • lower extremity implant
  • recent surgeries for heart or spine
  • cancer
  • hernia
  • acute thrombosis
  • kidney or bladder stones
  • diabetes
  • serious cardiovascular or cerebrovascular disease.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group A

group B

Arm Description

receive Qigong exercise in addition to traditional physical therapy program

receive traditional physical therapy program only

Outcomes

Primary Outcome Measures

Bone density measurement
The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2022
Last Updated
March 9, 2022
Sponsor
Eman Mohamed othman
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1. Study Identification

Unique Protocol Identification Number
NCT05276843
Brief Title
Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients
Official Title
Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eman Mohamed othman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
PURPOSE: to assess the efficacy of Qigong exercise on bone mineral density in post-burned patient. BACKGROUND: During severe burns, more than 7% of the vertebral bone mineral density (BMD) is lost within 3-6 weeks of the injury and about 3% of the total body bone content is lost during the first 6 months after the injury. Qigong exercise has been shown to be effective at attenuating declines in BMD and improving both balance performance and balance confidence in healthy middle-aged and older adults. There are lack in knowledge and information in published studies about the efficacy of Qigong exercise on bone mineral density in post-burned patient. So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on bone mineral density in post-burned patient. HYPOTHESES: It will be hypothesized that: It was hypothesized that Qigong exercise has no or limited effect in bone mineral density in post-burned patient. RESEARCH QUESTION: Does Qigong exercise an effect on bone mineral density in post-burned patient?
Detailed Description
Measurement procedure: Bone density measurement was conducted before the first session and after two months of treatment. The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual. Average bone mineral density = BMC/W (g/cm²). BMC = bone mineral content = g/cm. W = width at the scanned line. Data was graded according to Z score. Z-score: The Z-score is the comparison to the age matched normal subject. This is the number of standard deviations a patient's bone mineral density (BMD) differs from the average BMD of their age, sex and ethnicity. This value is used in premenopausal women, men under the age of 50, and in children. It is most useful when the score is less than 2 standard deviations below this normal. In this setting, it is helpful to scrutinize for coexisting illnesses that may contribute to osteoporosis such as glucocorticoid therapy, hyperparathyroidism or alcoholism. Z-score minus 1.5 and lower is considered below expected range of age, while Z-score above minus 1.5 is considered within expected range of age Treatment procedures: In this study the treatment protocol was presented in the form of an exercise program lasted for 50 minutes, twice weekly for 12 weeks postburn and consisted of weight bearing, strengthening and aerobic exercises and achieved under the following phases: Warming up phase: The main aim of this phase was to get the muscles warm and loose for strength training. The subject has to train for ten minutes on a stationary bicycle at a mild velocity before the beginning of each exercise session. Bicycling helps direct needed blood flow to the muscles and prepares the body for exercise. Warming up is important for preventing injury as well as gaining maximal benefit from the exercise, because loose and warm muscles respond better to the challenge of the program. Exercise phase: Qigong is a low-impact, weight-bearing exercise characterized by gentle movements designed to dissipate force throughout the body while the subject changes poses, with well-coordinated sequences of both isometric and isotonic segmental movements in the trunk and 4 extremities. This style emphasizes slow and smooth movement involving major muscle groups, at a constant speed while practicing. The sway of its moment is usually centered, which makes it more safe for the elderly to practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
receive Qigong exercise in addition to traditional physical therapy program
Arm Title
group B
Arm Type
No Intervention
Arm Description
receive traditional physical therapy program only
Intervention Type
Combination Product
Intervention Name(s)
Qigong exercise program
Intervention Description
Qigong is a low-impact, weight-bearing exercise characterized by gentle movements designed to dissipate force throughout the body while the subject changes poses, with well-coordinated sequences of both isometric and isotonic segmental movements in the trunk and 4 extremities.
Primary Outcome Measure Information:
Title
Bone density measurement
Description
The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual.
Time Frame
change in bone mineral density calculated at 8 weeks post treatment minus baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were 25-50 years old had thermal burn injuries of 2nd-3rd degree extended from the lower area of trunk to the lower extremities. the affected total body surface area of 30-45%. In the early burn stage (30-45 days in burn units), all patients were subjected to a unified physical therapy program consisted of positioning, range of motion, and gentle stretching exercises. Exclusion Criteria: any history of endocrine, metabolic or other systemic diseases prior or ongoing supplementation with calcium previous or current bone-specific drugs or diseases affecting bone metabolism smoking any neurogenic disorder impairing sensory or motor function use of drugs known to affect the central nervous system or equilibrium previous brain injury or any disease affecting balance history of epilepsy previous or habitual high-intensity exercise lower extremity arthralgia lower extremity implant recent surgeries for heart or spine cancer hernia acute thrombosis kidney or bladder stones diabetes serious cardiovascular or cerebrovascular disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eman othman, PhD
Phone
0020201120572128
Email
dr.emanothman@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eman othman, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
11432
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gehan el miniawi, PhD
Phone
002020237617691
Email
Info@pt.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
IPD Sharing Time Frame
1 year after publication
IPD Sharing Access Criteria
the criteria will be assessed by the publication of the trial in an international journals.

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Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients

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