NCT04315519

Brief Summary

Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

January 27, 2020

Last Update Submit

March 18, 2020

Conditions

Keywords

Blood Flow Restricted ExerciseType 2 DiabetesAerobic Exercise

Outcome Measures

Primary Outcomes (4)

  • Blood Glucose

    Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests

    up to 12 months

  • HbA1c

    Glycated hemoglobin, This data will be collected from teh individulas during routine test

    up to 12 months

  • Blood Glucose in Oral glucose Tolerance Test

    Blood Glucose in Oral glucose Tolerance Test, this data will be collected from the individuals during routine tests.

    Up to 12 months

  • Cardiorespiratory Fitness

    Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer.

    Up to 12 months

Secondary Outcomes (3)

  • The Strength of Quadriceps Muscle

    Up to 12 months

  • Fat Free Mass

    Up to 12 months

  • The Strength of Hamstring Muscle

    Up to 12 months

Study Arms (2)

Blood Flow Restricted Aerobic (BFRA)

EXPERIMENTAL

Low intensity Aerobic exercise with Blood Flow Restriction

Other: Exercise

Moderate Aerobic Exercise (MAE)

EXPERIMENTAL

moderate intensity aerobic exercise

Other: Exercise

Interventions

Aerobic Exercise

Blood Flow Restricted Aerobic (BFRA)Moderate Aerobic Exercise (MAE)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having Type 2 Diabetes
  • Not have been recruited any exercise programme for 6 months
  • Volunteering to participate in the study

You may not qualify if:

  • Nephropathy
  • Retinopathy
  • Have had myocardial infarction at least 6 months ago
  • Stable or unstable angina pectoris
  • The presence of peripheral artery disease
  • Resting blood pressure above 160/100 mmHg
  • Body mass index over 35 kg / m2
  • History of deep vein thrombosis, pulmonary embolism or stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 27, 2020

First Posted

March 19, 2020

Study Start

April 1, 2020

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

March 19, 2020

Record last verified: 2020-03