Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03913793
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2019-04-09
Brief Title:
Aerobic Training in Post-MI Patients With DPN
Sponsor:
Yousra Hisham Abdel Fattah
Organization:
University of Alexandria
Study Overview
Official Title:
Impact of Peripheral Neuropathy in Type-II Diabetes Mellitus on Outcome Measures of Weight-Bearing Aerobic Training in Post-Myocardial Infarction Patients
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ESCACCFAHAWHF 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 CRsystemic illness other than DM or hypertension neurological disorders other than DPN or had loss of protective sensation anesthesia andor 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 patientsSessions were 3 daysweek for 8 weeks The program included Warm up 10 minutes stretching exercises Aerobic exercise training using treadmill 30 - 60 minutessession 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 ischemicarrhythmic 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
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 CRsystemic illness other than DM or hypertension neurological disorders other than DPN or had loss of protective sensation anesthesia andor 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 patientsSessions were 3 daysweek for 8 weeks The program included Warm up 10 minutes stretching exercises Aerobic exercise training using treadmill 30 - 60 minutessession 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 ischemicarrhythmic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None