Differential Air Pressure Technology for Treatment of Diabetic Elderly Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Antigravity treadmill training 100% weight bearing

Antigravity treadmill training 75% weight bearing

Antigravity treadmill training 50% weight bearing

Antigravity treadmill training 25% weight bearing

The conventional exercise program

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Al Noor Specialized Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Arm Label

Treadmill training 100%

Treadmill training 75%

Treadmill training 50%

Treadmill training 25%

Conventional program

Arm Description

This group received antigravity treadmill training 100% weight bearing and conventional exercise program.

This group received antigravity treadmill training 75% weight bearing and conventional exercise program.

This group received antigravity treadmill training 50% weight bearing and conventional exercise program.

This group received antigravity treadmill training 25% weight bearing and conventional exercise program.

This group received the conventional exercise program only.

Outcomes

Primary Outcome Measures

Change from baseline functional capacity at 3 months

The assessment of functional capacity will be done using Six Minute Walk Test where intensity is moderately higher than daily living activities. Subject will be asked to walk at his own maximal pace from end to end of a 40-meter flat, straight corridor marked every 1 meter with side cones, in order to cover as much ground as possible while maintaining a steady pace without running during the allowed time. No verbal encouragement will be given, and subjects will be informed verbally each 2 minutes of the remaining time. The patients will be allowed to stop, but they can start again, if possible, within the allocated 6 minutes. Distance covered in 6 minutes will be recorded in meter. The longer the distance that will be walked will signify a better performance.

Change from baseline Health Related Quality of Life at 3 months

For assessment of Health Related Quality of Life, 36-item Medical Outcomes Study Short Form Questionnaire (Arabic version) will be used. Dimensions are physical functioning, social functioning, bodily pain, limitations caused by physical health problems; limitations caused by emotional problems, emotional well-being and mental health, energy-fatigue and vitality, general health perception. Participants' scores for Questionnaire will be computed following the protocol of Ware and associates and the higher scores mean better outcome.

Change from baseline Mobility at 3 months

Assessment of Mobility using Tinetti Performance Oriented Mobility Assessment. This is a widely recognized objective instrument for determining balance and gait deficiencies and assessing the risk of future falls. Higher Tinetti scores (maximum 28) correlate inversely with risk of falls. Individuals with Tinetti scores under 19 are considered to be at the highest risk for falls, those with scores between 19 and 24 are considered to have a moderate risk of falling, and those with scores 24 and above are considered to be at low risk for falls.

Change from baseline fall risk at 3 months

Fall risk assessment by using Balance Biodex stability system

Change from baseline spatial and temporal gait parameters at 3 months

Gait parameters assessment by using the GAITRite system. The main measured parameters will be step and stride length (cm), step width (cm), step time (sec), stance to swing ratio (%), cadence (steps/min) and velocity cm/sec.

Secondary Outcome Measures

Full Information

NCT ID

NCT04620265

First Posted

October 31, 2020

Last Updated

November 5, 2020

Sponsor

Umm Al-Qura University

1. Study Identification

Unique Protocol Identification Number

NCT04620265

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

October 1, 2020 (Actual)

Study Completion Date

October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Polyneuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treadmill training 100%

Arm Type

Experimental

Arm Description

This group received antigravity treadmill training 100% weight bearing and conventional exercise program.

Arm Title

Treadmill training 75%

Arm Type

Experimental

Arm Description

This group received antigravity treadmill training 75% weight bearing and conventional exercise program.

Arm Title

Treadmill training 50%

Arm Type

Experimental

Arm Description

This group received antigravity treadmill training 50% weight bearing and conventional exercise program.

Arm Title

Treadmill training 25%

Arm Type

Experimental

Arm Description

This group received antigravity treadmill training 25% weight bearing and conventional exercise program.

Arm Title

Conventional program

Arm Type

Sham Comparator

Arm Description

This group received the conventional exercise program only.

Intervention Type

Other

Intervention Name(s)

Antigravity treadmill training 100% weight bearing

Intervention Description

This group received antigravity treadmill training 100% weight bearing and conventional exercise program.

Intervention Type

Other

Intervention Name(s)

Antigravity treadmill training 75% weight bearing

Intervention Description

This group received antigravity treadmill training 75% weight bearing and conventional exercise program.

Intervention Type

Other

Intervention Name(s)

Antigravity treadmill training 50% weight bearing

Intervention Description

This group received antigravity treadmill training 50% weight bearing and conventional exercise program.

Intervention Type

Other

Intervention Name(s)

Antigravity treadmill training 25% weight bearing

Intervention Description

This group received antigravity treadmill training 25% weight bearing and conventional exercise program.

Intervention Type

Other

Intervention Name(s)

The conventional exercise program

Intervention Description

This group received the conventional exercise program only.

Primary Outcome Measure Information:

Title

Change from baseline functional capacity at 3 months

Description

The assessment of functional capacity will be done using Six Minute Walk Test where intensity is moderately higher than daily living activities. Subject will be asked to walk at his own maximal pace from end to end of a 40-meter flat, straight corridor marked every 1 meter with side cones, in order to cover as much ground as possible while maintaining a steady pace without running during the allowed time. No verbal encouragement will be given, and subjects will be informed verbally each 2 minutes of the remaining time. The patients will be allowed to stop, but they can start again, if possible, within the allocated 6 minutes. Distance covered in 6 minutes will be recorded in meter. The longer the distance that will be walked will signify a better performance.

Time Frame