Diabetic PolyneuropathyNCT05115747
Effect of Alter-G Training on Glycemic Control and Quality of Life in Diabetic Neuropathy
A study testing weight off-loading aerobic exercise training. in people with Diabetic Polyneuropathy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Aging is a natural process that is frequently accompanied by chronic physical or mental health problems. Aging as well as a sedentary lifestyle behavior may produce identical pathological and morphological changes. 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?
- weight off-loading aerobic exercise training.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jan 2021to 20 Oct 2021
- 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
- Participants with diabetic polyneuropathy,
- Diagnosed as having uncontrolled type 2 diabetes mellitus, with glycosylated hemoglobin (HbA1c) value between 7 and 11 and fasting glucose level ranged from 7.0 -11.1 mmol/L,
- Age range from 60 and 80 years old,
- Established type 2 diabetes mellitus duration over 10 years, treated only with oral anti-diabetic agents (not taking insulin), treated only with Biguanide alone or (Sulfonylureas plus Biguanide) oral anti-diabetic drugs combination, with pharmacological treatment had to be stable for at least 3 months before the study,
- Cognitively competent and able to understand and follow instructions, capable of rationally interacting with others; understanding and answering the health related quality of life questionnaire (HRQL).
Who cannot join
- Type 1 DM, treated with insulin therapy or oral anti-diabetic therapy other than Biguanide alone or (Sulfonylureas plus Biguanide) combination,
- Younger than 60 or older than 80 years old,
- 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,
- Active infection, drug abuse, participated in to an active rehabilitation program within last 6 months,
- With severe chronic or uncontrolled comorbid condition as recent myocardial infarction, unstable angina, acute congestive heart failure, third degree heart block and uncontrolled arrhythmia.
- With abnormal skin integrity e.g. wound or scares tissues or are on other complementary treatment,
- History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems) that could interfere with the evaluation or treatment efficacy and patient safety or precluded the patient from attending and completing the treatment sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lower Body Positive Pressure Aerobic Training on Glycemic Indices and Quality of Life in Patients With Diabetic Polyneuropathy: Randomized Controlled Trial
Aging is a natural process that is frequently accompanied by chronic physical or mental health problems. Aging as well as a sedentary lifestyle behavior may produce identical pathological and morphological changes. Saudi population, especially elderly people assume sedentary lifestyle, with little physical activity is a strong predisposition for developing a disability that adversely affects many aspects of physical and mental functions; mainly mobility and the ability to perform the basic daily living activities (ADL); resulting finally in increased risk of independence, loss of functionality, and falls. Type 2 diabetes mellitus (T2DM) is a widespread chronic metabolic disorder, accounts for 90-95% of all patients with diabetes. It is one of the most life-threatening public health challenges in the world, characterized by long term complications that almost involves all systems of the body. Polyneuropathy is the most common symptomatic complication in patients with type 2 diabetes mellitus, found in 50 to 60 % of patients over the age of sixty, with the impaired glycemic control and deteriorated quality of life are among the most debilitating problems in patients with diabetic polyneuropathy.
Read the detailed description
Regular physical activity is an important component in healthy aging. Regular activity is very beneficial to our health as we age. Physical therapy can play an important role in the evaluation and treatment of older people with gait and balance disorders. Physical Therapy can help in the determination of the impairments produced by balance and gait abnormality and develop individualized plans aiming for identification of functional limitations.
Lower extremity aerobic exercise training (e.g., walking, treadmill and bicycle ergometer) is a good procedure to control and disrupt the progression of hyperglycemia in elderly with DPN. Furthermore; it improves lower limb muscle oxygen uptake, enhances the nerve conduction and proprioceptors sensitivity during activities. Lowe extremity aerobic exercise training can enhance balance, thereby reducing the falling risk. Aerobic exercise is also helpful in preventing age related lifestyle disease and improving quality of life (QOL) of the elderly. A conflict was clearly evoked between prescribing weight bearing and non- weight bearing exercise for elderly with diabetic polyneuropathy.
Weight bearing theoretical basis assumes that weight bearing activities such as walking are superior to other non- weight- bearing activities because of its ability to promote and restore muscular strength, joint proprioception and range of motion necessary to effectively perform typical daily activities. Although weight bearing training can significantly improve walking and balance abilities in patients with diabetic polyneuropathy compared with non- weight bearing training, but there were still not enough evidences to prove the ideal percentage level of weight reduction or unloading during practicing lower extremity training exercise in elderly with diabetic polyneuropathy. Quite recently, a new antigravity treadmill based on The National Aeronautics and Space Administration (NASA) technology was introduced. It permits low- load walking using an emerging technology called lower body positive pressure (LBPP) to modify body weight during ambulation. Few trials handled the utilization of LBPP technology and further trials are still warranted to to develop a more effective conservative and intervention treatment protocol for enhancing physical activities, quality of life and functional performance in elderly patients with diabetic polyneuropathy.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- weight off-loading aerobic exercise training.
- Keywords
- Diabetic neuropathy,Quality of Life,Blood Glucose,Hemoglobin
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight off-loading aerobic exercise training.Other
Mild to moderate intensity weight off-loading aerobic exercise training on the anti-gravity Alter-G treadmill. (speed 8-12 mph, 50%-70% heart rate reserve "HRR", 12-16 score on the Borg's scale)
| Study group | Role | What they receive |
|---|---|---|
| "Zero percentage" weight off-loading group-A | Experimental | This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the full weight-bearing for three months. Receives: Other: weight off-loading aerobic exercise training. |
| "Twenty-five percentage" weight off-loading group-B | Experimental | This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the twenty-five percentage" weight off-loading for three months. Receives: Other: weight off-loading aerobic exercise training. |
| "Fifty percentage" weight off-loading group-C | Experimental | This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the fifty percentage" weight off-loading for three months. Receives: Other: weight off-loading aerobic exercise training. |
| "Seventy-five percentage" weight off-loading group-D | Experimental | This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the seventy-five percentage" weight off-loading for three months. Receives: Other: weight off-loading aerobic exercise training. |
| Control group-E | No intervention | Participated no aerobic exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the fasting blood glucose level "in mg/dl" at three months.
The fasting blood glucose (FBG) level "in mg/dl" will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the three-months Alter-G aerobic exercise training intervention (at the 12th week).
Measured: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)
Mean change in the fasting blood glucose level in "mg/dl" at six months.
The fasting blood glucose (FBG) level "in mg/dl" will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the six-months (three months post-training cessation).
Measured: Baseline and after six months (three months post-training cessation; at the 24th week).
Mean changes in the glycosylated hemoglobin level (HbA1c) at three months.
The glycosylated hemoglobin level (HbA1c) will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the three-months Alter-G aerobic exercise training intervention (at the 12th week).
Measured: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)
Mean changes in the glycosylated hemoglobin level (HbA1c) at six months.
The glycosylated hemoglobin level (HbA1c) will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the six-months (three months post-training cessation).
Measured: Baseline and after six months (three months post-training cessation; at the 24th week).
Secondary outcomes (2)
Mean changes in the health-related quality of life at three months.
The health-related quality of life will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the three-months Alter-G aerobic exercise training intervention (at the 12th week).
Measured: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)
Mean changes in the health-related quality of life at six months.
The health-related quality of life will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the six-months (three months post-training cessation).
Measured: Baseline and after six months (three months post-training cessation; at the 24th week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start15 Jan 2021
- Primary completion15 Oct 2021
- Study completion20 Oct 2021
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
- Model description
- This interventional study aims to explore the effectiveness of the lower body positive pressure aerobic exercise training program on the glycemic control and the health-related quality of life in patients with diabetic polyneuropathy. Eighty eligible participants were randomly allocated to either group-A (0-percentage weight off-loading; 16-participants), group-B (25-percentage weight off-loading; 15-participants), group-C (50-percentage weight off-loading; 16-participants), group-D (75-percentage weight off-loading; 15-participants), and group-E (control group; 18-participants). Participants in the study groups received twelve-weeks mild to moderate intensity aerobic training program on the Alter-G anti-gravity treadmill. The Glycemic control (Fasting blood glucose in mg/dl, glycated hemoglobin, and health-related quality of life were evaluated at three time points: at the beginning of the study, after three months aerobic exercise training and three months post-training cessation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Responsible party
- Principal investigator, Ashraf Abdelaal, Umm Al-Qura University
- Investigators
- ASHRAF AM ABDELAAL, Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115747
- Sponsor's protocol ID
- Umm AlQura Un
- Status last verified
- Dec 2023
- First submitted
- 30 Oct 2021
- Last updated
- 7 Dec 2023
- 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Body Positive Pressure Aerobic Training on Glycemic Indices and Quality of Life in Patients With Diabetic Polyneuropathy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05115747
- Acronym / sponsor ID
- Umm AlQura Un
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Diabetic neuropathy,Quality of Life,Blood Glucose,Hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 10 Nov 2021 (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 is a natural process that is frequently accompanied by chronic physical or mental health problems. Aging as well as a sedentary lifestyle behavior may produce identical pathological and morphological changes. Saudi population, especially elderly people assume sedentary lifestyle, with little physical activity is a strong predisposition for developing a disability that adversely affects many aspects of physical and mental functions; mainly mobility and the ability to perform the basic daily living activities (ADL); resulting finally in increased risk of independence, loss of functionality, and falls. Type 2 diabetes mellitus (T2DM) is a widespread chronic metabolic disorder, accounts for 90-95% of all patients with diabetes. It is one of the most life-threatening public health challenges in the world, characterized by long term complications that almost involves all systems of the body. Polyneuropathy is the most common symptomatic complication in patients with type 2 diabetes mellitus, found in 50 to 60 % of patients over the age of sixty, with the impaired glycemic control and deteriorated quality of life are among the most debilitating problems in patients with diabetic polyneuropathy.
Detailed description
Regular physical activity is an important component in healthy aging. Regular activity is very beneficial to our health as we age. Physical therapy can play an important role in the evaluation and treatment of older people with gait and balance disorders. Physical Therapy can help in the determination of the impairments produced by balance and gait abnormality and develop individualized plans aiming for identification of functional limitations.
Lower extremity aerobic exercise training (e.g., walking, treadmill and bicycle ergometer) is a good procedure to control and disrupt the progression of hyperglycemia in elderly with DPN. Furthermore; it improves lower limb muscle oxygen uptake, enhances the nerve conduction and proprioceptors sensitivity during activities. Lowe extremity aerobic exercise training can enhance balance, thereby reducing the falling risk. Aerobic exercise is also helpful in preventing age related lifestyle disease and improving quality of life (QOL) of the elderly. A conflict was clearly evoked between prescribing weight bearing and non- weight bearing exercise for elderly with diabetic polyneuropathy.
Weight bearing theoretical basis assumes that weight bearing activities such as walking are superior to other non- weight- bearing activities because of its ability to promote and restore muscular strength, joint proprioception and range of motion necessary to effectively perform typical daily activities. Although weight bearing training can significantly improve walking and balance abilities in patients with diabetic polyneuropathy compared with non- weight bearing training, but there were still not enough evidences to prove the ideal percentage level of weight reduction or unloading during practicing lower extremity training exercise in elderly with diabetic polyneuropathy. Quite recently, a new antigravity treadmill based on The National Aeronautics and Space Administration (NASA) technology was introduced. It permits low- load walking using an emerging technology called lower body positive pressure (LBPP) to modify body weight during ambulation. Few trials handled the utilization of LBPP technology and further trials are still warranted to to develop a more effective conservative and intervention treatment protocol for enhancing physical activities, quality of life and functional performance in elderly patients with diabetic polyneuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- This interventional study aims to explore the effectiveness of the lower body positive pressure aerobic exercise training program on the glycemic control and the health-related quality of life in patients with diabetic polyneuropathy. Eighty eligible participants were randomly allocated to either group-A (0-percentage weight off-loading; 16-participants), group-B (25-percentage weight off-loading; 15-participants), group-C (50-percentage weight off-loading; 16-participants), group-D (75-percentage weight off-loading; 15-participants), and group-E (control group; 18-participants). Participants in the study groups received twelve-weeks mild to moderate intensity aerobic training program on the Alter-G anti-gravity treadmill. The Glycemic control (Fasting blood glucose in mg/dl, glycated hemoglobin, and health-related quality of life were evaluated at three time points: at the beginning of the study, after three months aerobic exercise training and three months post-training cessation.
| Arm | Type | Receives |
|---|---|---|
| "Zero percentage" weight off-loading group-A | Experimental | Other: weight off-loading aerobic exercise training.This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the full weight-bearing for three months. |
| "Twenty-five percentage" weight off-loading group-B | Experimental | Other: weight off-loading aerobic exercise training.This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the twenty-five percentage" weight off-loading for three months. |
| "Fifty percentage" weight off-loading group-C | Experimental | Other: weight off-loading aerobic exercise training.This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the fifty percentage" weight off-loading for three months. |
| "Seventy-five percentage" weight off-loading group-D | Experimental | Other: weight off-loading aerobic exercise training.This group received the Mild to moderate aerobic exercise training on the Alter-G treadmill with the seventy-five percentage" weight off-loading for three months. |
| Control group-E | No intervention | –Participated no aerobic exercise training. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with diabetic polyneuropathy,
- Diagnosed as having uncontrolled type 2 diabetes mellitus, with glycosylated hemoglobin (HbA1c) value between 7 and 11 and fasting glucose level ranged from 7.0 -11.1 mmol/L,
- Age range from 60 and 80 years old,
- Established type 2 diabetes mellitus duration over 10 years, treated only with oral anti-diabetic agents (not taking insulin), treated only with Biguanide alone or (Sulfonylureas plus Biguanide) oral anti-diabetic drugs combination, with pharmacological treatment had to be stable for at least 3 months before the study,
- Cognitively competent and able to understand and follow instructions, capable of rationally interacting with others; understanding and answering the health related quality of life questionnaire (HRQL).
Key exclusion criteria (8 listed)
- Type 1 DM, treated with insulin therapy or oral anti-diabetic therapy other than Biguanide alone or (Sulfonylureas plus Biguanide) combination,
- Younger than 60 or older than 80 years old,
- 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,
- Active infection, drug abuse, participated in to an active rehabilitation program within last 6 months,
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 |
|---|---|---|
| weight off-loading aerobic exercise training.Mild to moderate intensity weight off-loading aerobic exercise training on the anti-gravity Alter-G treadmill. (speed 8-12 mph, 50%-70% heart rate reserve "HRR", 12-16 score on the Borg's scale) | Other | "Fifty percentage" weight off-loading group-C, "Seventy-five percentage" weight off-loading group-D, "Twenty-five percentage" weight off-loading group-B, "Zero percentage" weight off-loading group-A |
Primary outcome
Mean change in the fasting blood glucose level "in mg/dl" at three months.
Time frame: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)
The fasting blood glucose (FBG) level "in mg/dl" will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the three-months Alter-G aerobic exercise training intervention (at the 12th week).
Mean change in the fasting blood glucose level in "mg/dl" at six months.
Time frame: Baseline and after six months (three months post-training cessation; at the 24th week).
The fasting blood glucose (FBG) level "in mg/dl" will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the six-months (three months post-training cessation).
Mean changes in the glycosylated hemoglobin level (HbA1c) at three months.
Time frame: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)
The glycosylated hemoglobin level (HbA1c) will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the three-months Alter-G aerobic exercise training intervention (at the 12th week).
Mean changes in the glycosylated hemoglobin level (HbA1c) at six months.
Time frame: Baseline and after six months (three months post-training cessation; at the 24th week).
The glycosylated hemoglobin level (HbA1c) will be evaluated in all participants at the baseline (at the beginning of the study) and at the end of the six-months (three months post-training cessation).
2 secondary outcomes
Mean changes in the health-related quality of life at three months.
Time frame: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)
Mean changes in the health-related quality of life at six months.
Time frame: Baseline and after six months (three months post-training cessation; at the 24th week).
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 7 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetic Polyneuropathy
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Active, not recruitingObservational study
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy
RecruitingPhase 2
Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy
Diabetic Polyneuropathy
Not yet recruitingObservational study
Is Serum Irisin Level a Biomarker in Diabetic Polyneuropathy?
Polyneuropathies, Diabetic Complications Neurological
Recruiting
Normast3 for Adults With Diabetic Polyneuropathy
Diabete Type 2
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.
ASHRAF AM ABDELAAL principal investigator
Umm Al-Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight off-loading aerobic exercise training. 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 8 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 7 Dec 2023. 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. 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?
Mean change in the fasting blood glucose level "in mg/dl" at three months. (time frame: Baseline and post-three months aerobic exercise training intervention, (at the 12th week)). The study lists 4 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 7 Dec 2023.