Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2016-03-01
2018-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Neuropathy group
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
Exercise based-cardiac rehabilitation (EB-CR) program
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.
Non-Neuropathy group
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
Exercise based-cardiac rehabilitation (EB-CR) program
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.
Control group
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.
No interventions assigned to this group
Interventions
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Exercise based-cardiac rehabilitation (EB-CR) program
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.
Eligibility Criteria
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Inclusion Criteria
* DM according to the 2016 American Diabetes Association guidelines
Exclusion Criteria
* 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.
20 Years
70 Years
ALL
No
Sponsors
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Diaa Mohamed Mohasseb
UNKNOWN
Mahmoud Mohamed Hassanein
UNKNOWN
Gihan Younis El-tantawi
UNKNOWN
Aya Hanafy Ibrahiem
UNKNOWN
Yousra Hisham Abdel Fattah
OTHER
Responsible Party
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Yousra Hisham Abdel Fattah
Principle investigator
Other Identifiers
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0104363
Identifier Type: -
Identifier Source: org_study_id
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