Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients

Diabetic Neuropathies Clinical Trial

Official title:

Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332378
• Other study ID #: sHasan
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2024
• Source: University of Karachi
• Contact: Sobia Hasan, PhD*
• Phone: 03343063044
• Email: sobia.hasan[@]iqra.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians. 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 waist circumference, and BMI. 3. Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients. 4. Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients. 5. Comparative effects of two therapeutic exercises and control group on Neuropathy. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with type II diabetic neuropathy
• 40-70 year's old patient, will be refer by physicians.

Exclusion Criteria:

• lower extremity complications 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
• interruption of the intervention sessions for more than two days

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Other:
• 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 Flex and extend one leg, heel sliding down a straight line on table. 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 Place foot forward and backward on a straight line. Walk along a winding strip. 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

Locations

Country	Name	City	State
Pakistan	Ameen Medical & Dental Centre	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sobia Hasan

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One Leg Stance	One Leg Stance assesses postural stability. This test includes standing on one foot without any help. This vary according to age.40-49 years-old (eyes open): 40 seconds. 50-59 years-old (eyes open): 37 seconds .; 60-69 years-old (eyes open): 26.9 seconds. 70-79 years-old (eyes open): 18.3 seconds. These are normal values less than normal values indicate postural instability	6 weeks
Primary	Berg Balance Scale	The Berg Balance Scale, is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.	6 weeks
Primary	Timed Up and Go Test:	Measures the time it takes for an individual to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down. < 10 seconds = normal. < 20 seconds = good mobility; can walk outside alone; does not require a walking aid. < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.	6 weeks
Primary	Diabetic Neuropathy Symptom Score	Diabetic Neuropathy Symptom (DNS) score is a diabetic neuropathy screening consisting of scores from 1 to 4, and a score of =1 is considered significant. The severity of diabetic neuropathy was measured using an England score consisting of mild, moderate, and severe.	6 weeks
Primary	Hemoglobin A1C	HbA1c is short for glycated Haemoglobin. The test is also sometimes called Haemoglobin A1c. Haemoglobin (Hb) is the protein in red blood cells that carries oxygen through your body. HbA1c refers to glucose and haemoglobin joined together (the haemoglobin is 'glycated').An A1c level of 7 percent is considered high and means that 7% of the hemoglobin in your blood is saturated with sugar. HbA1c (%) levels of women and men in different age groups in HbA1c <6.5 and HbA1c =6.5 groups.; 30-39: 5.34; 40-49: 5.49; 50-59 : 5.65. A1c levels of 6.5 or greater are considered diabetes.	8 weeks