Effect of Alter-G Training on Glycemic Control and Quality of Life in Diabetic Neuropathy

NCT05115747 | Completed DMC

• 1 other identifier: Umm AlQura Un
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetic Polyneuropathy

Keywords

Diabetic neuropathy,Quality of Life,Blood Glucose,Hemoglobin

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  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.

  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.

  Baseline and after six months (three months post-training cessation; at the 24th week).

Study Arms (5)

"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.

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.

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.

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.

Other: weight off-loading aerobic exercise training.

Control group-E

NO INTERVENTION

Participated no aerobic exercise training.

Interventions

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)

"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

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead
• King AbdulAziz City for Science and Technology: collaborator

Study Sites (1)

Umm Al-Qura University

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

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

Study Officials

• ASHRAF AM ABDELAAL

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double: (Participants and outcome assessors). * Participants' random allocation was conducted by an independent person. The participants were unaware of the percentage of weight off-loading during the treadmill aerobic exercise training. * Outcomes Assessor kept blind about the group's allocation and the applied exercise training protocols.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 10, 2021
• Study Start: January 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 20, 2021
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)