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

NCT05276843 | Unknown

• 1 other identifier: 00000000
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

group A

EXPERIMENTAL

receive Qigong exercise in addition to traditional physical therapy program

Combination Product: Qigong exercise program

group B

NO INTERVENTION

receive traditional physical therapy program only

Interventions

Qigong exercise program COMBINATION_PRODUCT

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.

group A

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eman Mohamed othman: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• eman othman, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

eman othman, PhD

CONTACT

0020201120572128; dr.emanothman@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 11, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 1 year after publication
• Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.

Locations

EG (1)