Clinical trial NCT06332378: Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
Official title: Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy Type 2
Keywords: Exercise Therapy
Diabetic Neuropathies
Type 2 Diabetes Mellitus
Michigan Neuropathy Screening Instrument
Lead sponsor: University of Karachi
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


Eligibility criteria: 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

Primary outcomes:
measure: One Leg Stance
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: Timed Up and Go Test:
timeFrame: 6 weeks
measure: Diabetic Neuropathy Symptom Score
timeFrame: 6 weeks
measure: Hemoglobin A1C
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ameen Medical & Dental Centre
state: Sindh
Study officials:
affiliation: Ameen Medical center
name: Sobia Hasan, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Iqra University, North Campus, Karachi, Pakistan
name: Aftab Ahmed Mirza Baig, PhD
role: STUDY_DIRECTOR
References:
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: 10.2147/DMSO.S261175. eCollection 2020.
citation: 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.