NCT05803824

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 19, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 27, 2023

Last Update Submit

November 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Brief Fatigue Inventory (BFI)

    The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.he BFI is a reliable and valid tool with a low respondent burden, suitable for measuring fatigue in burn patients during the first year of recovery.

    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 Outcomes (2)

  • b. The timed up and go (TUG) test

    3 months

  • c. The Activities-specific Balance (ABC) scale

    3months

Study Arms (2)

group A: Baduanjin Qigong exercise plus selected exercise

EXPERIMENTAL

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 at group B: patients will receive selected exercise program

EXPERIMENTAL

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

Interventions

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

Patients at group B: patients will receive selected exercise programgroup A: Baduanjin Qigong exercise plus selected exercise

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) 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

You may not qualify if:

  • )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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy , Cairo university

Giza, Egypt

Location

Study Officials

  • Hassan

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

December 30, 2022

Primary Completion

August 30, 2023

Study Completion

December 1, 2023

Last Updated

November 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

after 6months we will share the study protocol and informed consent.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
after 6 months of study

Locations