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Aerobic Training in Post-MI Patients With DPN

Primary Purpose

Myocardial Infarction, Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise based-cardiac rehabilitation (EB-CR) program
Sponsored by
Yousra Hisham Abdel Fattah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed as having MI according to the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of MI
  • DM according to the 2016 American Diabetes Association guidelines

Exclusion Criteria:

  • contraindication to exercise stress test (EST)
  • contraindication to cardiac rehabilitation,
  • systemic illness other than DM or hypertension,
  • neurological disorders other than DPN,
  • had loss of protective sensation (anesthesia)
  • had ulcerations in the lower limbs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Neuropathy group

    Non-Neuropathy group

    Control group

    Arm Description

    post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction with peripheral neuropathy , enrolled into exercise program From those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital

    post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction without peripheral neuropathy , enrolled into exercise program From those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital

    post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction, not enrolled into exercise program.

    Outcomes

    Primary Outcome Measures

    Duke Activity Status Index (DASI) questionnaire
    12 questions of self-administered questionnaire that measures a patient's functional capacity, The index included questions about activities of daily living as personal care, house hold activities and recreational activities. It also correlated activities with peak oxygen uptake. Maximum value 58.2 and Minimum value 0, higher values indicate better functional capacity. Estimated peak oxygen uptake in mL/min = (0.43 * (duke activity status index) + 9.6
    heart rate (HR)
    number of heart beats per minute,
    blood pressure (BP),
    systolic and diastolic blood pressure in mmHg
    rate pressure product (RPP),
    is a measure of the stress put on the cardiac muscle based on the number of times it needs to beat per minute (HR) and the arterial blood pressure that it is pumping against
    Six minute walk test distance
    It is used to estimate the functional capacity of the study group. It was done according to the American Thoracic Society (ATS) guidelines for the 6MWT. The 6MWT was performed in an indoors flat straight corridor of 30 meters in length. A stopwatch was used to measure the 6 minutes. Patients were instructed that the target of the test was to: WALK AS FAR AS POSSIBLE for 6 minutes, WITHOUT RUNNING OR JOGGING

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2019
    Last Updated
    April 10, 2019
    Sponsor
    Yousra Hisham Abdel Fattah
    Collaborators
    Diaa Mohamed Mohasseb, Mahmoud Mohamed Hassanein, Gihan Younis El-tantawi, Aya Hanafy Ibrahiem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03913793
    Brief Title
    Aerobic Training in Post-MI Patients With DPN
    Official Title
    Impact of Peripheral Neuropathy in Type-II Diabetes Mellitus on Outcome Measures of Weight-Bearing Aerobic Training in Post-Myocardial Infarction Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    May 30, 2018 (Actual)
    Study Completion Date
    September 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yousra Hisham Abdel Fattah
    Collaborators
    Diaa Mohamed Mohasseb, Mahmoud Mohamed Hassanein, Gihan Younis El-tantawi, Aya Hanafy Ibrahiem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Cardiac rehabilitation (CR) is categorized by the American College of Cardiology "class IA recommendation" in the management of patients with cardiovascular disease (CVD) including post-myocardial infarction (MI) patients, who have reduced functional capacity and impaired quality of life. Studies have reported that post-MI patients enrolled in exercise-based CR (EB-CR) show improved functional capacity, significant decrease risk of re-infarction, and 25% reduction in mortality. Aim: To define the effect of diabetic peripheral neuropathy (DPN) on the outcome measures of exercise based-cardiac rehabilitation (EB-CR) program in post-myocardial infarction (MI) patients with type-II diabetes mellitus (DM). Methods: Thirty-seven post-MI patients with type-II DM were enrolled in the study within 1-6 months of MI from those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital. Seven patients were lost. Fifteen patients attended 8 weeks of aerobic training program (exercise group; 12 men and 3 women) while 15 patients did not (control group; 11 men and 4 women). The exercise group was assessed for the presence of peripheral neuropathy and patients were accordingly subdivided into those with DPN "group A" and those without "group B". All groups were evaluated at baseline and at the end of the study. Evaluation included Duke Activity Status Index (DASI) questionnaire, 6-minute walk test, and symptom-limited treadmill exercise stress test (EST). Outcome measures included: DASI score; 6-minute walk test distance (6MWD); and heart rate (HR), blood pressure (BP), rate pressure product (RPP), and functional capacity in metabolic equivalents (METs) measured during EST.
    Detailed Description
    The study population included post-MI patients with type-II DM within 1 to 6 months from onset of MI from those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital. Patients were diagnosed as having MI according to the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of MI and DM according to the 2016 American Diabetes Association guidelines. All patients were assessed by a cardiologist by clinical examination, electrocardiogram and echocardiography. Patients were excluded if they had any contraindication to exercise stress test (EST) or CR,systemic illness other than DM or hypertension, neurological disorders other than DPN, or had loss of protective sensation (anesthesia) and/or ulcerations in the lower limbs. All patients were informed about the nature of the study and an informed consent was obtained from all of them. The protocol was approved by the ethics committee. Patients were divided into 2 groups; those enrolled in EB-CR program "exercise group" and those not enrolled in EB-CR program "control group". Baseline evaluation for both groups included: demographic data collection, history taking, clinical examination, electrophysiological studies to confirm the presence or absence of neuropathy (sural sensory, posterior tibial and deep peroneal motor conduction studies), total neuropathy score to assess the clinical severity of DPN, Duke Activity Status Index questionnaire (DASI) to assess patients' physical activity level, Six-Minute Walk Test, and symptom-limited treadmill EST using Bruce protocol. All patients were on their regular medications including B-blockers during the EST. The exercise group underwent an outpatient EB-CR program (phase II) according to the American College of Sports Medicine guidelines for exercise prescription for cardiac patients.Sessions were 3 days/week for 8 weeks. The program included: Warm up (10 minutes): stretching exercises. Aerobic exercise training using treadmill (30 - 60 minutes/session): with target heart rate (HR) at 45 - 75% of HR reserve. The maximal HR (HR max) was derived from that obtained during EST. Patients who had ischemic/arrhythmic manifestations during EST, exercise intensity was prescribed at a HR below the ischemic threshold (10 beats below). Cool down (10 minutes): light intensity treadmill walking. Supervision was provided according to the risk status of each patient that was determined according to the American Association of cardiovascular and Pulmonary Rehabilitation criteria for risk stratification. Controls were advised to maintain their medications and regular activities of daily living. The follow-up evaluation included: DASI, Six Minute Walk Test and symptom limited EST. The Outcome measures were DASI score, Six-minute walk test distance (6MWD), functional capacity in metabolic equivalents (METs), HR, blood pressure (BP) and rate pressure product (RPP) at a given workload.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction, Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Neuropathy group
    Arm Type
    Active Comparator
    Arm Description
    post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction with peripheral neuropathy , enrolled into exercise program From those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital
    Arm Title
    Non-Neuropathy group
    Arm Type
    Active Comparator
    Arm Description
    post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction without peripheral neuropathy , enrolled into exercise program From those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction, not enrolled into exercise program.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise based-cardiac rehabilitation (EB-CR) program
    Intervention Description
    The exercise group underwent an outpatient EB-CR program (phase II) according to the American College of Sports Medicine guidelines for exercise prescription for cardiac patients.[19] Sessions were 3 days/week for 8 weeks. The program included: (1) Warm up (10 minutes): stretching exercises. (2) Aerobic exercise training using treadmill (30 - 60 minutes/session): with target heart rate (HR) at 45 - 75% of HR reserve. The maximal HR (HR max) was derived from that obtained during exercise stress test (EST). Patients who had ischemic/arrhythmic manifestations during EST, exercise intensity was prescribed at a HR below the ischemic threshold (10 beats below). (3) Cool down (10 minutes): light intensity treadmill walking. Supervision was provided according to the risk status of each patient that was determined according to the American Association of cardiovascular and Pulmonary Rehabilitation criteria for risk stratification.
    Primary Outcome Measure Information:
    Title
    Duke Activity Status Index (DASI) questionnaire
    Description
    12 questions of self-administered questionnaire that measures a patient's functional capacity, The index included questions about activities of daily living as personal care, house hold activities and recreational activities. It also correlated activities with peak oxygen uptake. Maximum value 58.2 and Minimum value 0, higher values indicate better functional capacity. Estimated peak oxygen uptake in mL/min = (0.43 * (duke activity status index) + 9.6
    Time Frame
    8 weeks
    Title
    heart rate (HR)
    Description
    number of heart beats per minute,
    Time Frame
    8 weeks
    Title
    blood pressure (BP),
    Description
    systolic and diastolic blood pressure in mmHg
    Time Frame
    8 weeks
    Title
    rate pressure product (RPP),
    Description
    is a measure of the stress put on the cardiac muscle based on the number of times it needs to beat per minute (HR) and the arterial blood pressure that it is pumping against
    Time Frame
    8 weeks
    Title
    Six minute walk test distance
    Description
    It is used to estimate the functional capacity of the study group. It was done according to the American Thoracic Society (ATS) guidelines for the 6MWT. The 6MWT was performed in an indoors flat straight corridor of 30 meters in length. A stopwatch was used to measure the 6 minutes. Patients were instructed that the target of the test was to: WALK AS FAR AS POSSIBLE for 6 minutes, WITHOUT RUNNING OR JOGGING
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed as having MI according to the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of MI DM according to the 2016 American Diabetes Association guidelines Exclusion Criteria: contraindication to exercise stress test (EST) contraindication to cardiac rehabilitation, systemic illness other than DM or hypertension, neurological disorders other than DPN, had loss of protective sensation (anesthesia) had ulcerations in the lower limbs.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Aerobic Training in Post-MI Patients With DPN

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