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Baduanjin Qigong Exercise Plus Selected Exercise Program on Chronic Fatigue Syndrome and Postural Imbalance Following Lower Limb Burn Injury. (Burn)

Primary Purpose

Lower Limb Burn Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Burn Injury

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    group A: Baduanjin Qigong exercise plus selected exercise

    group B: patients will receive Baduanjin Qigong exercise only

    Patients at group C: patients will receive selected exercise program

    Arm Description

    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 .

    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 .

    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 .

    Outcomes

    Primary Outcome Measures

    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.
    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

    Secondary Outcome Measures

    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
    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.

    Full Information

    First Posted
    March 27, 2023
    Last Updated
    June 13, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05803824
    Brief Title
    Baduanjin Qigong Exercise Plus Selected Exercise Program on Chronic Fatigue Syndrome and Postural Imbalance Following Lower Limb Burn Injury.
    Acronym
    Burn
    Official Title
    Efficacy of Baduanjin Qigong Exercise Plus Selected Exercise Program on Chronic Fatigue Syndrome and Postural Imbalance Following Lower Limb Burn Injury.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lower Limb Burn Injury

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    group A: Baduanjin Qigong exercise plus selected exercise
    Arm Type
    Experimental
    Arm Description
    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 .
    Arm Title
    group B: patients will receive Baduanjin Qigong exercise only
    Arm Type
    Experimental
    Arm Description
    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 .
    Arm Title
    Patients at group C: patients will receive selected exercise program
    Arm Type
    Experimental
    Arm Description
    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 .
    Intervention Type
    Other
    Intervention Name(s)
    exercise therapy program
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    a. Chalder Fatigue Scale (ChFS).
    Description
    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.
    Time Frame
    3months
    Title
    b. The dynamic balance score
    Description
    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
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    b. The timed up and go (TUG) test
    Description
    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
    Time Frame
    3 months
    Title
    c. The Activities-specific Balance (ABC) scale
    Description
    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.
    Time Frame
    3months
    Other Pre-specified Outcome Measures:
    Title
    e. The OMNI scale
    Description
    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
    Time Frame
    3months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    after 6months we will share the study protocol and informed consent.
    IPD Sharing Time Frame
    after 6 months of study

    Learn more about this trial

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

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