Alter-G Training on Gait and Balance in Diabetic Neuropathy Patients

NCT ID: NCT05565924

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2022-06-08

Brief Summary

Diabetic Peripheral Neuropathy and associated complications became globally serious arousing health problems.

Aim: To evaluate the effect of Antigravity treadmill training on gait performance and functional balance in patients with Diabetic Peripheral Neuropathy.

Design: Single-blinded randomized controlled trial. Setting: Outpatient rehabilitation unit. Population: Sixty-eight eligible participants with Diabetic Peripheral Neuropathy were randomly allocated to Five groups: group-A (100% weight-bearing; n=14), group-B (70% weight-bearing; n=13), group-C (50% weight-bearing; n=14), group-D (30% weight-bearing; n=13), group-E (control group; n=14).

Methods: Participants in study groups A, B, C, and D received moderate intensity (50-70% heart rate reserve) aerobic exercise training program on the antigravity treadmill (AlterG, Inc., Fremont, CA, USA) 3 times/week for 12-weeks. The gait performance (using the dynamic gait index) and the functional balance (using the Berg balance scale) variables were evaluated at 3-time points: baseline (evaluation-1), after 12 training weeks (evaluation-2), and 3 months post-training cessation (evaluation-3).

Detailed Description

Diabetic Peripheral neuropathy is the most common serious diabetes-related complication affecting more than one-third of patients with diabetes especially those with type 2 diabetes. Diabetic Peripheral neuropathy is defined as the existence of clinical indicators of neural dysfunction after excluding other causes in patients with diabetes and is usually affecting the sensory nerves before the motor ones, following the distal to proximal pattern distribution. Type 2 diabetes-related microangiopathy, neural ischemia, and demyelination are the commonly encountered pathophysiological endpoints responsible for Diabetic Peripheral neuropathy-related neural lesions. The Diabetic Peripheral neuropathy-related proprioceptive inputs impairments further predispose patients to frequently disturbed static and dynamic balance as well as impaired gait performance. Controversy existed regarding the efficacy of the weight-support aerobic exercise training on the locomotion, gait, and functional variables in patients with Diabetic Peripheral neuropathy. Researchers initially thought that weight-bearing exercise training is more beneficial in improving physical function than non-weight-bearing exercise training in patients with Diabetic Peripheral neuropathy. Few studies reported non-significant functional effects of the increased weight support, while others reported beneficial effects of the partial weight off-loading aerobic exercise training on the gait, balance, and functional performance in patients with Diabetic Peripheral neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group-A

This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill (100% weight-bearing; n=14) 3 times/week for 12-weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Group Type: EXPERIMENTAL

Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Intervention Type: OTHER

Moderate-intensity aerobic exercise training on the antigravity treadmill (100% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).

Group-B

This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training (70% weight-bearing; n=13) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) 3 times/week for 12 weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Group Type: EXPERIMENTAL

Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Intervention Type: OTHER

Moderate-intensity aerobic exercise training on the antigravity treadmill (70% weight-bearing) plus medications plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)

Group-C

This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training (50% weight-bearing; n=14) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA), 3 times/week for 12 weeks plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Group Type: EXPERIMENTAL

Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Intervention Type: OTHER

Moderate-intensity aerobic exercise training on the antigravity treadmill (50% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)

group-D (30% weight-bearing; n=13)

This group received moderate-intensity aerobic exercise training (30% weight-bearing; n=13) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) 3 times/week for 12 weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Group Type: EXPERIMENTAL

Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Intervention Type: OTHER

Moderate-intensity aerobic exercise training on the antigravity treadmill (30% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).

group-E (control group; n=14)

Served as a control group and participated in no aerobic exercise training on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) during the study, but received oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Group Type: SHAM_COMPARATOR

Group- E; Control group

Intervention Type: OTHER

Control: No aerobic exercise training on the antigravity treadmill, but only medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) throughout the study.

Interventions

Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Moderate-intensity aerobic exercise training on the antigravity treadmill (100% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).

Intervention Type: OTHER

Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Moderate-intensity aerobic exercise training on the antigravity treadmill (70% weight-bearing) plus medications plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)

Intervention Type: OTHER

Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Moderate-intensity aerobic exercise training on the antigravity treadmill (50% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)

Intervention Type: OTHER

Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.

Moderate-intensity aerobic exercise training on the antigravity treadmill (30% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).

Intervention Type: OTHER

Group- E; Control group

Control: No aerobic exercise training on the antigravity treadmill, but only medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) throughout the study.

Intervention Type: OTHER

Other Intervention Names

Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").; Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").; Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").; Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").; Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Eligibility Criteria

Inclusion Criteria

• Elderly with diabetic polyneuropathy.
• Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) levels between 7 and 11 and fasting glucose levels ranging 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.
• Able to walk independently with or without an assistive device.
• Scored 19 points or less in the "dynamic gait index.

Exclusion Criteria

• Type 1 Diabetes Mellitus,
• Patient with malnutrition (Body mass index < 21 kg/m2 or with recent weight loss > 5% body weight in the last month or > 10% in six months).
• Patients With any severe chronic or uncontrolled comorbid condition such 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. wounds or scar tissues or are on other complementary treatments.
• History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umm Al-Qura University

OTHER

Sponsor Role: lead

Responsible Party

Ashraf Abdelaal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf Abdelaal

Role: PRINCIPAL_INVESTIGATOR

Umm Al-Qura University

Locations

Umm Al-Qura University

Jeddah, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

13-MED1319-10_IR1

Identifier Type: -

Identifier Source: org_study_id