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

NCT06616805 | Completed

• 1 other identifier: P.T.REC/012/004815
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (2)

• albumin/creatinine ratio

  Random urine samples will be collected from patients before and after the end of treatment sessions for measuring al/Cr ratio

  change in 12 weeks

• Glycated hemoglobin

  blood samples will be collected from patients before and after the end of treatment sessions for measuring HBA1C

  change in 12 weeks

Secondary Outcomes (1)

• blood pressure

  change in 12 weeks

Study Arms (2)

low-volume High Intensity Interval Training

EXPERIMENTAL

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.

Device: treadmill

Moderate Intensity Continuous Training

EXPERIMENTAL

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

Device: treadmill

Interventions

treadmill 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; low-volume High Intensity Interval Training

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.
• \. Microalbuminuria (UAE \>30µg /min and \<299µg /min)

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo University

Giza, Cairo Governorate, 11432, Egypt

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Heba Ali Abd El Ghafar, A.professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: quadruple (participant, care provider, investigator, outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Model Details: patients will be randomly assigned into two groups group A and group B. group A will receive low-volume high intensity interval training and group B will receive moderate intensity continuous training.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: January 1, 2024
• Primary Completion: July 29, 2024
• Study Completion: August 30, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)