Clinical trial NCT05691738: Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy
Official title: The Effect of Modified Otago Exercises on Metabolic Parameters, Joint Position Sense, Balance and Health-Related Physical Fitness Parameters in Individuals With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Neuropathy
Keywords: Otago Exercise
Joint Position Sense
Balance
Physical Fitness
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Ankara Yildirim Beyazıt University
First posted: 2023-01-20
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of modified otago exercises on joint position sense, balance and physical fitness parameters in individuals with diabetic neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and to gain exercise awareness in diabetic individuals.


Eligibility criteria: Inclusion Criteria:

* Individuals with Neuropathy Diagnosed with Type 2 Diabetes between the Ages of 40-65 Years
* Cooperative, able to take instructions (Mini Mental Test score of 24 and above)
* Able to walk independently
* With a Body Mass Index Below 40 Kg/M2
* Not Doing Regular Physical Activity for the Last 6 Months
* Voluntarily participated in the research

Exclusion Criteria:

* Additional neurological problem other than neuropathy
* Any orthopedic or systemic problems that will prevent him from performing the exercises
* The presence of pathology related to the lower limb that occurred within the last 6 months (surgery, fracture, soft tissue injuries, etc.)
* Pregnant
* Vision problem that cannot be corrected with glasses or lenses
* Hearing loss that cannot be corrected with hearing aids
* Foot ulcer
* Patients who have been diagnosed with cancer and are receiving chemotherapy in this context
* With limitation of the range of motion of the joints of the lower extremities

Primary outcomes:
measure: Blood Glucose Level
timeFrame: Change from baseline at 8 weeks
measure: Blood Cholesterol Level
timeFrame: Change from baseline at 8 weeks
measure: Blood Triglycerides Level
timeFrame: Change from baseline at 8 weeks
measure: Blood HDL Cholesterol Level
timeFrame: Change from baseline at 8 weeks
measure: Blood LDL Cholesterol Level
timeFrame: Change from baseline at 8 weeks
measure: Joint Position Sense Evaluation
timeFrame: Change from baseline at 8 weeks
measure: The Timed Up & Go (Functional Mobility Assessment)
timeFrame: Change from baseline at 8 weeks
measure: Balance Evaluation
timeFrame: Change from baseline at 8 weeks
measure: Body Mass İndex Evaluation
timeFrame: Change from baseline at 8 weeks
measure: Body Weight
timeFrame: Change from baseline at 8 weeks
measure: Body Fat Percentage
timeFrame: Change from baseline at 8 weeks
measure: Lean Body Weight
timeFrame: Change from baseline at 8 weeks
measure: Cardio-respiratory Fitness Evaluation
timeFrame: Change from baseline at 8 weeks
measure: Sit and Reach Test (Flexibility ) Evaluation
timeFrame: Change from baseline at 8 weeks
measure: Muscle Strength (30-second Chair Stand Test) Evaluation
timeFrame: Change from baseline at 8 weeks
measure: Falling Risk
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Cognitive Status
timeFrame: a day before the start of treatment
measure: Neuropathic Pain Scale
timeFrame: Change from baseline at 8 weeks
measure: Individual Exercise İntensity
timeFrame: a day before the start of treatment
measure: Monofilament Evaluation
timeFrame: a day before the start of treatment
measure: Diaposan (Vibration) Evaluation
timeFrame: a day before the start of treatment
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Provincial Health Directorate Karaman Training and Research Hospital
state: Center
Study officials:
affiliation: Karamanoğlu Mehmetbey University
name: ALİ CEYLAN, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Yildirim Beyazıt University
name: Ertuğrul DEMİRDEL, PhD
role: STUDY_CHAIR
References: