OTAGO Exercises in Diabetes Mellitus Examining Its Effectiveness

NCT07705958 | Not Yet Recruiting

• 1 other identifier: DM123
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetes Mellitus (DM) is a chronic metabolic disease characterized by hyperglycemia, which occurs in insulin deficiency or when the body cannot effectively use the insulin produced. Moreover, according to the "Global Report on Diabetes" data published by the World Health Organization (WHO) in 2016, it is an important public health problem, one of the four priority non-communicable diseases (1, 2). In addition to the high mortality rates caused by complications due to DM, it is also known that it can cause low quality of life and many other additional problems in individuals. Possible complications are chronic and serious problems such as heart attack, risk of stroke, kidney failure, vision loss and nerve damage. One of the most common and most disabling complications is neuropathy. It should also be noted that approximately half of diabetic neuropathy is asymptomatic and patients diagnosed with DM may have neuropathy due to causes other than diabetes (2). These complications and damage that DM can cause can lead to decreased blood flow combined with neuropathy; As a result, foot ulcers and infections may occur; Amputation rates may increase. In addition to such additional complications that diabetic neuropathy may cause, due to all these; Loss of protective plantar sensation may also occur (3). This loss of protective sensation may lead to cutaneous deficits in the lower extremities, loss of muscle strength and reflexes, and gait and balance disorders (4). The mechanism that makes an important contribution to functional joint stability and the continuity of this stability, along with the feedback mechanisms required to ensure neuromuscular control, is proprioception, which includes joint movement (kinesthesia) and joint position sense (EPH) and is a subunit of the somatosensory system (5-7). . Rehabilitation with various injuries and other clinical conditions; Clinical studies to determine its effects on joint proprioception, neuromuscular control and balance have mostly focused on knee and ankle joints (5). The main reason for this can be attributed to the great importance of the knee and ankle joints in the lower extremities in maintaining general body kinematics and balance (8). Additionally, it has been reported in the literature that EPH and plantar sensory loss are observed in individuals diagnosed with DM, and these complications may cause additional problems (10, 12, 18-22). Additionally, many studies in the literature on this subject have been conducted in individuals with diabetic neuropathy, and changes in functional parameters such as plantar sensation, proprioception, muscle strength and balance have been examined (10, 19, 20, 22, 23). However, it has been found that not only individuals with neuropathy but also individuals diagnosed with DM without neuropathy have balance disorders (24). There are many studies in the literature about the effects of different exercise training on proprioception. In general, studies have reported that exercise training without weight bearing on the extremity has no effect on proprioception, but as a result of exercises performed with weight bearing on the extremity, a significant improvement was noted in both proprioceptive performance and muscle strength (25). In one of the most recent studies on this subject, it was stated that proprioceptive sensitivity increased in individuals with knee osteoarthritis with 8-week squat strengthening training performed by transferring weight to the extremity (26). Additionally, there are studies in the literature reporting different results regarding the effects of stretching exercises on proprioceptive performance. Some studies have reported that static stretching has no effect on proprioception, while others have reported that it has a positive effect on proprioception (27,28). The Otago Exercise Program is an evidence-based, home-based, individually tailored strength and balance retraining program. Research shows that the Otago Exercise Program is effective in reducing the risk of death and the incidence of falls in older adults over a one-year period. In one study, falls were reduced by 35% in older adults has been reported(29) This study was planned to examine the effectiveness of balance exercises given as a home program to individuals diagnosed with Type 2 DM.

Conditions

Diabetes Mellitus; Balance

Keywords

balance; otago exercise; Diabetes mellitus

Outcome Measures

Primary Outcomes (4)

• Get Up and Go Test

  The Timed Up and Go (TUG) test assesses functional mobility and dynamic balance. The time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down will be recorded in seconds. Lower values indicate better functional mobility.

  Baseline and Week 4

• 30 seconds Sit and Stand Test:

  The 30-Second Sit-to-Stand Test assesses lower extremity muscle strength and functional performance by recording the number of complete sit-to-stand repetitions performed from a standard chair within 30 seconds. Higher scores indicate better lower extremity functional strength.

  Baseline and 4 weeks after intervention

• Modified Falls Efficacy Scale [MFES])

  The Modified Falls Efficacy Scale (MFES) is a self-reported questionnaire used to assess an individual's confidence in performing daily activities without falling. Scores range from 0 to 10 for each item, with higher scores indicating greater confidence and lower fear of falling.

  Baseline and 4 weeks after intervention

• Audit of Diabetes Dependent Quality of Life (ADDQoL

  The Audit of Diabetes-Dependent Quality of Life (ADDQoL) is a validated diabetes-specific questionnaire used to assess the impact of diabetes on quality of life across multiple life domains. Higher negative scores indicate a greater adverse impact of diabetes on quality of life, whereas scores closer to zero or positive values indicate a lesser impact or better diabetes-related quality of life.

  Baseline and 4 weeks after intervention

Study Arms (2)

Training group

EXPERIMENTAL

Balance exercises are within the scope of the Otago exercise program and will be given as a home program. They will be asked to do it for 40 minutes, 5 days a week for 4 weeks. Both groups will be asked to walk for half an hour 2 days a week. Patients will be given a follow-up form and will be called weekly.

Behavioral: Experimental: Training Group

control group

ACTIVE COMPARATOR

Only walking will be recommended.

Behavioral: Experimental: Training Group

Interventions

Experimental: Training Group BEHAVIORAL

Otago exercises and walking will be recommended for the balance group, and only walking will be recommended for the control group. Balance exercises are within the scope of the Otago exercise program and will be given as a home program. They will be asked to do it for 40 minutes, 5 days a week for 4 weeks. Both groups will be asked to walk for half an hour 2 days a week. Patients will be given a follow-up form and will be called weekly.

Training group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases diagnosed with Diabetes Mellitus,
• Cases that do not have any orthopedic/neurological/cardiopulmonary disease other than Diabetes Mellitus that will directly affect the evaluation results,
• Having agreed to participate in the study voluntarily,
• Having been diagnosed with Type 2 DM for at least 1 year

You may not qualify if:

• Not agreeing to participate in the study,
• Individuals with additional diseases other than DM that will affect the evaluations,
• Having a smoking habit or history
• Restriction in joint movements or any orthopedic/neurological/cardiopulmonary disease that may cause this,
• Not being able to cooperate,
• Having vision loss,
• Having hearing loss,
• Having a diabetic ulcer on the foot,

Sponsors & Collaborators

• Pamukkale University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Phd

Model Details: Balance exercises are within the scope of the Otago exercise program and will be given as a home program. They will be asked to do it for 40 minutes, 5 days a week for 4 weeks. Both groups will be asked to walk for half an hour 2 days a week. Patients will be given a follow-up form and will be called weekly.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share