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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Burns
• Intervention / Treatment: Combination product: Qigong exercise program

Detailed Description

1. 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

2. 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:

1. 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.

2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: eman othman, PhD; Phone Number: 0020201120572128; Email: dr.emanothman@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt, 11432
    • Faculty of physical therapy
    • Contact: gehan el miniawi, PhD; Phone Number: 002020237617691; Email: Info@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; receive Qigong exercise in addition to traditional physical therapy program	Combination product: Qigong exercise program; 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.
No Intervention: group B; receive traditional physical therapy program only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change in bone mineral density calculated at 8 weeks post treatment minus baseline.

Collaborators and Investigators

• Sponsor: Eman Mohamed othman
• Investigators: Study Chair: eman othman, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 00000000 (Other Identifier: UCDavis IRB exempt)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No