- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06332378
Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
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:
- To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
- Effectiveness of exercises using Swiss ball in lowering waist circumference, and BMI.
- Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients.
- Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sobia Hasan, PHD*
- Phone Number: 03343063044
- Email: sobia.hasan@iqra.edu.pk
Study Contact Backup
- Name: Dr.Basit Ansari, PHD
- Phone Number: 0322279221
- Email: basitansari@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Experimental: ball training exercise
|
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: Frenkel training exercise
|
Frenkel Exercises Supine 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One Leg Stance
Time Frame: 6 weeks
|
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
|
Berg Balance Scale
Time Frame: 6 weeks
|
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
|
Timed Up and Go Test:
Time Frame: 6 weeks
|
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
|
Diabetic Neuropathy Symptom Score
Time Frame: 6 weeks
|
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
|
Hemoglobin A1C
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sobia Hasan, PhD*, Ameen Medical center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sHasan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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