Differential Air Pressure Technology for Treatment of Diabetic Elderly Patients

NCT04620265 | Completed DMC

• 1 other identifier: Umm AlQura Univ
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline and 3 months post-intervention

• 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.

  Baseline and 3 months post-intervention

• 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.

  Baseline and 3 months post-intervention

• Change from baseline fall risk at 3 months

  Fall risk assessment by using Balance Biodex stability system

  Baseline and 3 months post-intervention

• 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.

  Baseline and 3 months post-intervention

Study Arms (5)

Treadmill training 100%

EXPERIMENTAL

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

Other: Antigravity treadmill training 100% weight bearing; Other: The conventional exercise program

Treadmill training 75%

EXPERIMENTAL

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

Other: Antigravity treadmill training 75% weight bearing; Other: The conventional exercise program

Treadmill training 50%

EXPERIMENTAL

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

Other: Antigravity treadmill training 50% weight bearing; Other: The conventional exercise program

Treadmill training 25%

EXPERIMENTAL

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

Other: Antigravity treadmill training 25% weight bearing; Other: The conventional exercise program

Conventional program

SHAM COMPARATOR

This group received the conventional exercise program only.

Other: The conventional exercise program

Interventions

Antigravity treadmill training 100% weight bearing OTHER

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

Treadmill training 100%

Antigravity treadmill training 75% weight bearing OTHER

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

Treadmill training 75%

Antigravity treadmill training 50% weight bearing OTHER

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

Treadmill training 50%

Antigravity treadmill training 25% weight bearing OTHER

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

Treadmill training 25%

The conventional exercise program OTHER

This group received the conventional exercise program only.

Conventional program; Treadmill training 100%; Treadmill training 25%; Treadmill training 50%; Treadmill training 75%

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Al Noor Specialized Hospital

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Weight-Bearing

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Shamekh M El-Shamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 6, 2020
• Study Start: March 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)