Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
NCT ID: NCT06332378
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2024-05-05
2024-12-28
Brief Summary
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Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..
The main question it aims to answer are:
1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
2. Effectiveness of exercises using Swiss ball in lowering BMI.
3. To assess the effectiveness of exercise interventions on fasting blood sugar (FBS) levels and glycosylated hemoglobin (HbA1c) in individuals with Type II diabetes.
4. To evaluate the effectiveness of exercise interventions on autonomic nervous system activity in patients with Type II diabetic peripheral neuropathy.
5. To assess the comparative effectiveness of two therapeutic exercise interventions and a control group in improving the Michigan Neuropathy Screening Instrument (MNSI) score.
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).
Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ball training exercise
Experimental group 1 :Ball training
Ball training Training in sitting position (the participants sat on the ball and did the exercises): holding balance position on the ball, active movements (flexion, extension, abduction, adduction) of one upper extremity, active movement of two upper extremities, trunk movements (bending forward and rotation), raising heel, raising toes, raising heel and toes simultaneously, resistance against perturbation, and weight shifting on ball and 2-Training in standing position: moving the ball up and down in a straight line with two upper extremities, moving the ball up and down in an oblique line with two upper extremities, moving the ball forward and backward with left and right lower extremities, moving the ball laterally with left and right lower extremities, throwing the ball against the wall with hand, throwing the ball against the wall with foot
Frenkel training exercise
Experimental group 2 :Frenkel Exercises
Frenkel Exercises Supine position
1. Flex and extend one leg, heel sliding down a straight line on table.
2. Abduct and adduct leg with knee and hip extended, leg sliding on table. Sitting position
1\. Place foot on therapist's hand, which will change position. 2. Raise leg and put foot on traced footprint on the wall. 3. Rise and sit with knees together. Standing position
1. Place foot forward and backward on a straight line.
2. Walk along a winding strip.
3. Walk between two parallel lines
control group
Control Group
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30
Interventions
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Experimental group 1 :Ball training
Ball training Training in sitting position (the participants sat on the ball and did the exercises): holding balance position on the ball, active movements (flexion, extension, abduction, adduction) of one upper extremity, active movement of two upper extremities, trunk movements (bending forward and rotation), raising heel, raising toes, raising heel and toes simultaneously, resistance against perturbation, and weight shifting on ball and 2-Training in standing position: moving the ball up and down in a straight line with two upper extremities, moving the ball up and down in an oblique line with two upper extremities, moving the ball forward and backward with left and right lower extremities, moving the ball laterally with left and right lower extremities, throwing the ball against the wall with hand, throwing the ball against the wall with foot
Experimental group 2 :Frenkel Exercises
Frenkel Exercises Supine position
1. Flex and extend one leg, heel sliding down a straight line on table.
2. Abduct and adduct leg with knee and hip extended, leg sliding on table. Sitting position
1\. Place foot on therapist's hand, which will change position. 2. Raise leg and put foot on traced footprint on the wall. 3. Rise and sit with knees together. Standing position
1. Place foot forward and backward on a straight line.
2. Walk along a winding strip.
3. Walk between two parallel lines
Control Group
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30
Eligibility Criteria
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Inclusion Criteria
* 40-70 year's old patient, will be refer by physicians.
Exclusion Criteria
* having experience dislocation at least six months prior to the study
* having any history of surgical operations in muscles, bones, and joints of lower extremities,
* suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report)
* knee joint flexion contracture
* interruption of the intervention sessions for more than two days
40 Years
70 Years
ALL
No
Sponsors
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Dr. Sobia Hasan
OTHER
Responsible Party
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Dr. Sobia Hasan
Dr.Sobia Hasan
Principal Investigators
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Sobia Hasan, PhD*
Role: PRINCIPAL_INVESTIGATOR
Ameen Medical center
Aftab Ahmed Mirza Baig, PhD
Role: STUDY_DIRECTOR
Iqra University, North Campus, Karachi, Pakistan
Locations
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Ameen Medical & Dental Centre
Karachi, Sindh, Pakistan
Countries
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References
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Melese H, Alamer A, Hailu Temesgen M, Kahsay G. Effectiveness of Exercise Therapy on Gait Function in Diabetic Peripheral Neuropathy Patients: A Systematic Review of Randomized Controlled Trials. Diabetes Metab Syndr Obes. 2020 Aug 5;13:2753-2764. doi: 10.2147/DMSO.S261175. eCollection 2020.
Francia P, De Bellis A, Iannone G, Sinopoli R, Bocchi L, Anichini R. The Role of New Technological Opportunities and the Need to Evaluate the Activities Performed in the Prevention of Diabetic Foot with Exercise Therapy. Medicines (Basel). 2021 Dec 2;8(12):76. doi: 10.3390/medicines8120076.
Other Identifiers
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sHasan
Identifier Type: -
Identifier Source: org_study_id