Effect of High Intensity Interval Versus Moderate Intensity Continuous Training on Microalbuminurea

NCT ID: NCT06616805

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-08-30

Brief Summary

purpose: to investigate the effect of low-volume high-intensity interval training and moderate- intensity continuous training on microalbuminuria in patients with diabetic nephropathy. methods: forty patients with microalbuminurea will be recruited and randomly assigned to two groups, group A and group B. patients in group A will receive low-volume HIIT and patients in group B will receive MICT. All patients will be evaluated pre and post treatment for laboratory investigation for ( HBa1c, ACR),and blood pressure.

Detailed Description

1. procedures for evaluation: the practical part of the study will be undertaken in 12 weeks(3 sessions a week).measurement will be taken before the start of treatment program then after the end of 12 weeks treatment program in the following manner:

1. Anthropometric measures: body mass index (BMI) in kg/m2, waist circumference.

2. Blood pressure measurement: Systolic and diastolic blood pressure.

3. Biochemical (Lab) analysis:HbA1c, Urinary albumin test (Albumin/Creatinine ratio).

4. Treadmill Graded exercise test:(Modified Bruce protocol) It will be used before starting of exercise sessions to determine maximum heart rate reached during this test and to predict individualized training target heart rate and training intensity for each patient before training.

2. Treatment procedures: All subjects in the exercise groups A&B will perform the exercise interventions using a treadmill 3 sessions per week for 12 weeks. In the early beginning, patients in all groups will receive an educational session about dietary guidelines for type 2 diabetes.

Group (A): low-volume High Intensity Interval Training Patients in this group will undergo a warm-up at low intensity for 10 minutes, and then they will perform a single bout protocol that consisted of 1×4 min at 80-90% HRmax. Finally, a 5-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.

Group (B): Moderate Intensity Continuous Training Each session will start with a 10-minute warm-up at low intensity. Then they will walk on a treadmill for 30 min at moderate intensity corresponding to 65-75% of HR-max. Finally, a 5-min cool-down period will be permitted.

Conditions

Diabetic Nephropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

low-volume High Intensity Interval Training

Group (A): low-volume High Intensity Interval Training Patients in this group will undergo a warm-up at low intensity for 10 minutes, and then they will perform a single bout protocol that consisted of 1×4 min at 80-90% HRmax. Finally, a 5-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.

Group Type: EXPERIMENTAL

treadmill

Intervention Type: DEVICE

Treadmill JAGUAR treadmill:( T900, China) motorized treadmill model (T900) motor power (6.OHP) input voltage (AC220-240 V, 50Hz) speed range (1-20KM/H), inclination range (1-15%) was used for exercise treatment

Moderate Intensity Continuous Training

Group (B): Moderate Intensity Continuous Training Each session will start with a 10-minute warm-up at low intensity. Then they will walk on a treadmill for 30 min at moderate intensity corresponding to 65-75% of HR-max. Finally, a 5-min cool-down period will be permitted

Group Type: EXPERIMENTAL

treadmill

Intervention Type: DEVICE

Treadmill JAGUAR treadmill:( T900, China) motorized treadmill model (T900) motor power (6.OHP) input voltage (AC220-240 V, 50Hz) speed range (1-20KM/H), inclination range (1-15%) was used for exercise treatment

Interventions

treadmill

Treadmill JAGUAR treadmill:( T900, China) motorized treadmill model (T900) motor power (6.OHP) input voltage (AC220-240 V, 50Hz) speed range (1-20KM/H), inclination range (1-15%) was used for exercise treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. Type II diabetes mellitus 2. Age between 40 to 55 years old. 3. Blood pressure less than or equals 160/100 mmHg. 4. Patients receiving oral hypoglycemic. 5. Increased urinary albumin excretion (UAE)in the absence of other renal diseases.

6. Microalbuminuria (UAE >30µg /min and <299µg /min)

Exclusion Criteria

• 1. Patients with Cardiac diseases. 2. Patients with chest diseases (Bronchial asthma and chronic obstructive pulmonary disease).

3. Patients with severe self-limiting illness(cancer). 4. Musculoskeletal or neurological limitations to physical exercise. 5. Patients using insulin therapy. 6. Patients with poorly controlled DM (HbA1c > 9%). 7. Systolic Blood pressure more than 160 mmHg. 8. Morbid obesity. 9. Severe neuropathy. 10. PAD (claudication). 11. Retinopathy (moderate /advanced).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Mohamed Ali Hussein

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba Ali Abd El Ghafar, A.professor

Role: STUDY_DIRECTOR

Cairo University

Locations

faculty of physical therapy, Cairo University

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004815

Identifier Type: -

Identifier Source: org_study_id