Qigong Exercise Plus Selected Exercise Program and Lower Limb Burn Injury (Burn)

Efficacy of Baduanjin Qigong Exercise Plus Selected Exercise Program on Chronic Fatigue Syndrome and Postural Imbalance Following Lower Limb Burn Injury

90 patients who suffer from chronic fatigue syndrome and postural imbalance following Lower Limb Burn Injury. will be selected from outpatient clinic, faculty of physical therapy, Cairo university. Patients will be assigned randomly into 3 groups of equal numbers, group A: (Study group A) will receive Baduanjin Qigong exercise plus selected exercise program. group B:(Study group B) will receive Baduanjin Qigong exercise, Group C (control group C) will receive selected exercise program .

Study Overview

• Status: Completed
• Conditions: Lower Limb Burn Injury
• Intervention / Treatment: Other: exercise therapy program

Detailed Description

Patients at group A: patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects practiced Baduanjin exercise 3 times or above each week, 30- 60 minutes each time for 8 weeks. The subjects were required to complete the program in the fixed site and in a collective manner, with special personnel recording the attendance and providing guidance. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up to regulate the internal organs, (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft to regulate the functions of the spleen and stomach, (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body to relieve stress, (7) moving the hands down the back and legs and touching the feet to strengthen the kidneys, (8) thrusting the fists and making the eyes glare to enhance strength, and (9) raising and lowering the heels to cure diseases .

Selected Exercise Program: Patients will receive

• balance exercises 3 sessions a week for 8 weeks in the form of balance exercises and resisted exercises. Balance Exercises Each session of balance exercises is composed of three phases, including warm-up, balance training and cool down. The warm-up phase involved gentle stretching for calf, hamstring, quadriceps, iliopsoas muscles, as well as anterior, posterior and lateral step-ups for 5-10 minutes. The active phase was performed on a balance training mat of high-elasticity for 20 minutes. It included heel and toe raises, one-legged stance for each extremity, shifting weight anteriorly, posteriorly, laterally and diagonally. turning head to the right and then to the left with maintaining the feet together, walking in slow motion, step-ups, narrow walking, backward walking, sideward walking, stepping over obstacles, passing balls arranged on the training mat in a circle, and throwing and catching a ball on the training mat. The program ended with 5-10 minutes of cool down. During the cool-down phase, patients performed deep breathing exercises and static exercises for back extensor in a recumbent position.
• Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises for hip flexors and extensor, knee extensors and flexors, and ankle dorsiflexors. The exercises' intensity was progressed as the following; week one: 50-60% of three repetition maximum (3RM), from 2nd -6th weeks: 70- 75% of 3RM and for 7th -8th weeks: 80-85% 3RM for 4- 10 repetitions ,3 sessions a week for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • faculty of physical therapy , Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) age of the patient was ranged from 35 to 55 years; 2) weight range 60-85 kg, height 155- 170 cm; 3) total burned surface area (TBSA) was 20- 35% measured by the rule of nines; 4) the burn cause was thermal; 5) burn depth, partial-thickness burn injury; 6) at least 3 months after burn injuries; 7) and with low physical activity level

Exclusion Criteria:

• 1)inhalation injury; 2) leg amputation; 3) any limitation in LL range of motion; 4) auditory or visual problems; 5) congenital musculoskeletal deformities, especially in the foot; 6) psychiatric disorders; 7) paralysis; or 8) cardiac abnormalities or cardiac pacemakers.

In order to apply the inclusion and exclusion criteria, all cases will be subjected to an interview and assessment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A: Baduanjin Qigong exercise plus selected exercise; Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels . Puls Selected Exercise Program; balance exercises is composed of three phases, including warm-up, balance training and cool down.; Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises .	Other: exercise therapy program; patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects will recive Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels . Selected Exercise Program: Patients will receive; balance exercises is composed of three phases, including warm-up, balance training and cool down.; Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises
Experimental: group B: patients will receive Baduanjin Qigong exercise only; the subjects will receive Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels .	Other: exercise therapy program; patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects will recive Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels . Selected Exercise Program: Patients will receive; balance exercises is composed of three phases, including warm-up, balance training and cool down.; Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises
Experimental: Patients at group C: patients will receive selected exercise program; Selected Exercise Program: Patients will receive; balance exercises is composed of three phases, including warm-up, balance training and cool down.; Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises .	Other: exercise therapy program; patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects will recive Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels . Selected Exercise Program: Patients will receive; balance exercises is composed of three phases, including warm-up, balance training and cool down.; Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a. Chalder Fatigue Scale (ChFS).	The ChFS is a 14-item self-rating scale on the severity of physical fatigue (8 items) and mental fatigue symptoms (6 items). A higher score is suggestive of greater severity of fatigue.	3months
b. The dynamic balance score	c. The dynamic balance score that was measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). Biodex Balance System is a valid and reliable method to assess the dynamic balance. The system has a movable circular platform that permits about 20◦ tilt in 360◦ range so it is free to move about the anterior-posterior and mediallateral directions simultaneously	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
b. The timed up and go (TUG) test	e. The timed up and go (TUG) test is a basic mobility assessment tool that records the time taken (in seconds) to get up from a chair, walk 3-meter distance, come back and sit down again on the chair	3 months
c. The Activities-specific Balance (ABC) scale	d. The Activities-specific Balance (ABC) scale is a popular and subjective questionnaire to assess balance confidence and the risk of fall in people with balance problems.34 The ABC scale consisted of 16 items with a total score between 0% (not confident) to 100% (completely confident), where higher scores equate to higher balance confidence and vice versa. The Arabic version of the ABC scale is reliable and valid in the assessment of balance confidence.	3months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
e. The OMNI scale	b. The OMNI scale for Rating of Perceived Exertion (RPE) was utilized to monitor the subject's perceived effort during the fatigue protocol. The OMNI scale quantifies perceived effort on a 0- 10 scale using a chart with 0 corresponding to "extremely easy" and 10 corresponding to "extremely hard." The OMNI scale has previously been found to be a valid and reliable method of measuring effort in exercising adults	3months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hassan, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Burns; Wounds and Injuries
• Other Study ID Numbers: 2451981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after 6months we will share the study protocol and informed consent.
• IPD Sharing Time Frame: after 6 months of study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; 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