Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- One Leg Stance
Study Overview
Brief 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:
- 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 BMI.
- To assess the effectiveness of exercise interventions on fasting blood sugar (FBS) levels and glycosylated hemoglobin (HbA1c) in individuals with Type II diabetes.
- To evaluate the effectiveness of exercise interventions on autonomic nervous system activity in patients with Type II diabetic peripheral neuropathy.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ball training exercise
Intervention: Experimental group 1 :Ball training (Other)
Frenkel training exercise
Intervention: Experimental group 2 :Frenkel Exercises (Other)
control group
Intervention: Control Group (Other)
Outcomes
Primary Outcomes
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
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.
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.
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. 1. 30-39: 5.34 2. 40-49: 5.49 3. 50-59 : 5.65. A1c levels of 6.5 or greater are considered diabetes.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Sobia Hasan
Dr.Sobia Hasan
University of Karachi