Diabetic PolyneuropathyNCT04620265
Differential Air Pressure Technology for Treatment of Diabetic Elderly Patients
A study testing Antigravity treadmill training 100% weight bearing, Antigravity treadmill training 75% weight bearing and Antigravity treadmill training 50% weight bearing in people with Diabetic Polyneuropathy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Antigravity treadmill training 100% weight bearing, Antigravity treadmill training 75% weight bearing and Antigravity treadmill training 50% weight bearing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2020to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Air Pressure Technology for Improving Gait Performance and Reducing Fall Risk in Diabetic Elderly Saudi Patients
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.
Read the 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.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- 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
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigravity treadmill training 100% weight bearingOther
This group received antigravity treadmill training 100% weight bearing and conventional exercise program.
Antigravity treadmill training 75% weight bearingOther
This group received antigravity treadmill training 75% weight bearing and conventional exercise program.
Antigravity treadmill training 50% weight bearingOther
This group received antigravity treadmill training 50% weight bearing and conventional exercise program.
Antigravity treadmill training 25% weight bearingOther
This group received antigravity treadmill training 25% weight bearing and conventional exercise program.
The conventional exercise programOther
This group received the conventional exercise program only.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training 100% | Experimental | This group received antigravity treadmill training 100% weight bearing and conventional exercise program. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Antigravity treadmill training 25% weight bearing; Other: The conventional exercise program |
| Conventional program | Sham comparator | This group received the conventional exercise program only. Receives: Other: The conventional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months post-intervention
Change from baseline fall risk at 3 months
Fall risk assessment by using Balance Biodex stability system
Measured: 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.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Mar 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamekh Mohamed El-Shamy, Umm Al-Qura University
- Investigators
- Shamekh M El-Shamy, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620265
- Sponsor's protocol ID
- Umm AlQura Univ
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Air Pressure Technology for Improving Gait Performance and Reducing Fall Risk in Diabetic Elderly Saudi Patients
- ClinicalTrials.gov ID
- NCT04620265
- Acronym / sponsor ID
- Umm AlQura Univ
- Conditions
- Diabetic Polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treadmill training 100% | Experimental | Other: Antigravity treadmill training 100% weight bearing, Other: The conventional exercise programThis group received antigravity treadmill training 100% weight bearing and conventional exercise program. |
| Treadmill training 75% | Experimental | Other: Antigravity treadmill training 75% weight bearing, Other: The conventional exercise programThis group received antigravity treadmill training 75% weight bearing and conventional exercise program. |
| Treadmill training 50% | Experimental | Other: Antigravity treadmill training 50% weight bearing, Other: The conventional exercise programThis group received antigravity treadmill training 50% weight bearing and conventional exercise program. |
| Treadmill training 25% | Experimental | Other: Antigravity treadmill training 25% weight bearing, Other: The conventional exercise programThis group received antigravity treadmill training 25% weight bearing and conventional exercise program. |
| Conventional program | Sham comparator | Other: The conventional exercise programThis group received the conventional exercise program only. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antigravity treadmill training 100% weight bearingThis group received antigravity treadmill training 100% weight bearing and conventional exercise program. | Other | Treadmill training 100% |
| Antigravity treadmill training 75% weight bearingThis group received antigravity treadmill training 75% weight bearing and conventional exercise program. | Other | Treadmill training 75% |
| Antigravity treadmill training 50% weight bearingThis group received antigravity treadmill training 50% weight bearing and conventional exercise program. | Other | Treadmill training 50% |
| Antigravity treadmill training 25% weight bearingThis group received antigravity treadmill training 25% weight bearing and conventional exercise program. | Other | Treadmill training 25% |
| The conventional exercise programThis group received the conventional exercise program only. | Other | Conventional program, Treadmill training 100%, Treadmill training 25%, Treadmill training 50%, Treadmill training 75% |
Primary outcome
Change from baseline functional capacity at 3 months
Time frame: Baseline and 3 months post-intervention
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
Time frame: Baseline and 3 months post-intervention
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
Time frame: Baseline and 3 months post-intervention
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
Time frame: Baseline and 3 months post-intervention
Fall risk assessment by using Balance Biodex stability system
Change from baseline spatial and temporal gait parameters at 3 months
Time frame: Baseline and 3 months post-intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamekh M El-Shamy, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antigravity treadmill training 100% weight bearing, Antigravity treadmill training 75% weight bearing and Antigravity treadmill training 50% weight bearing in people with Diabetic Polyneuropathy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline functional capacity at 3 months (time frame: Baseline and 3 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.