Aerobic Training in Post-MI Patients With DPN
Impact of Peripheral Neuropathy in Type-II Diabetes Mellitus on Outcome Measures of Weight-Bearing Aerobic Training in Post-Myocardial Infarction Patients.
1 other identifier
interventional
37
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedApril 12, 2019
April 1, 2019
2.2 years
April 9, 2019
April 10, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
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
8 weeks
heart rate (HR)
number of heart beats per minute,
8 weeks
blood pressure (BP),
systolic and diastolic blood pressure in mmHg
8 weeks
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
8 weeks
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
8 weeks
Study Arms (3)
Neuropathy group
ACTIVE COMPARATORpost-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
Non-Neuropathy group
ACTIVE COMPARATORpost-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
Control group
NO INTERVENTIONpost-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction, not enrolled into exercise program.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yousra Hisham Abdel Fattahlead
- Diaa Mohamed Mohassebcollaborator
- Mahmoud Mohamed Hassaneincollaborator
- Gihan Younis El-tantawicollaborator
- Aya Hanafy Ibrahiemcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 12, 2019
Study Start
March 1, 2016
Primary Completion
May 30, 2018
Study Completion
September 30, 2018
Last Updated
April 12, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share