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Completed

NCT Number: 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:

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.

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Key information

Conditions

Diabetic Nephropathy Type 2 Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ameen Medical & Dental Centre

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental group 1 :Ball training

Other

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

Other

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
  • 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

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

    • 30-39: 5.34
    • 40-49: 5.49
    • 50-59 : 5.65. A1c levels of 6.5 or greater are considered diabetes.

Sponsors and collaborators

Lead sponsor

Dr. Sobia Hasan

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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