Clinical trial NCT04620265: Differential Air Pressure Technology for Treatment of Diabetic Elderly Patients
Official title: Differential Air Pressure Technology for Improving Gait Performance and Reducing Fall Risk in Diabetic Elderly Saudi Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Aging can be defined as sequential deterioration that occurs in elderly people including weakness, loss of mobility, decline of physical capabilities, increase susceptibility to disease and many other age-related physiological changes .The beginning of old age in most developed countries is about 60 or 65 years old. Diabetes mellitus (DM) and most commonly type 2 DM is one of the most common chronic non-communicable diseases affecting old people in Saudi Arabia which might be resulted from decline in physical activities. Polyneuropathy (PN) and its serious consequences represent the most common complication in diabetic mellitus which could contribute to an increased gait abnormality and risk of falling.

Detailed description: Disability and reduction of quality of life are the largest costs of diabetes and its complications. So taking active intervention to reduce the risk of falls, improve gait performance and improve the quality of life in elderly with DPN is very important. Lower extremity aerobic exercise training via treadmill aiming for improving patients' physical activity levels is an important part in the rehabilitation program to enhance balance and walking functions and reducing the fall risk, .Treadmill training using s low-load walking provided by an emerging technology called lower body positive pressure (LBPP) that effectively reduces body weight could be preferable than other methods of unweighting treadmill because the air pressure is applied uniformly over the lower body. This kind of anti-gravity treadmill is ideal in reducing the formation of pain and pressure points that are common with harness-based unweighting systems. Many other advantages are also associated with this unique type of antigravity technology that could give it the superiority than the other types of unweighting treadmills in enhancing walking performance, reducing the risk of fall and improving quality of life in Saudi elderly people with DPN.

Eligibility criteria: Inclusion Criteria:

* Elderly Saudi men with diabetic polyneuropathy with history of 2 or more falls within the past 12 months
* Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated haemoglobin (HbA1c) level between 7 and 11 and fasting glucose level ranged from 7.0 -11.1 mmol/L.
* Treated only with oral anti-diabetic agents (not taking insulin),
* Pharmacological treatment had to be stable for at least 3 months before the study.
* They will be selected among old subjects that were able to walk independently with or without assistive device but with poor balance

Exclusion Criteria:

* Type 1 Diabetes Mellitus,
* Patients who had got a score over 19 according to Tinetti scale of balance assessment,
* Patient with malnutrition (BMI \< 21 kg/m2 or with recent weight loss \> 5% body weight in the last month or \> 10% in six months),
* Patients with established hypertension (resting systolic blood pressure \> 140 mmHg and diastolic blood pressure \> 90 mmHg,
* With any severe chronic or uncontrolled comorbid condition as recent myocardial infarction, unstable angina, acute congestive heart failure, third degree heart block and uncontrolled arrhythmia.
* Patients will be excluded also if they have abnormal skin integrity e.g. wound or scare tissues or are on other complementary treatment,
* History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).

Primary outcomes:
measure: Change from baseline functional capacity at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline Health Related Quality of Life at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline Mobility at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline fall risk at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline spatial and temporal gait parameters at 3 months
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Al Noor Specialized Hospital
Study officials:
affiliation: Professor
name: Shamekh M El-Shamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: