Power Walking in Cardiac Patients Who Underwent Post-coronary Angioplasty

NCT04610060 | Completed

• 1 other identifier: INT/COHS/PG/015-2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The risk and prevalence of cardiovascular disease in United Arab Emirates (UAE) is high with ischemic heart disease ranks first in terms of major cause of mortality. Large number of patients undergoes coronary angioplasty but very few participate in cardiac rehabilitation because its awareness is not widespread in middle east region. The objectives was to find the influence of standardized outpatient cardiac rehabilitation program along with power walking on Heart quality of life (Heart QoL), functional exercise capacity, Left Ventricular Ejection Fraction and metabolic equivalent task (MET's) among patients with post coronary angioplasty. The investigators conducted a randomized clinical trail in out patient physiotherapy department at Thumbay hospitals Dubai, on patients who underwent coronary artery angioplasty. After meeting the inclusion criteria, participants were randomized into standardized outpatient cardiac rehabilitation program along with power walking (intervention group) or standardized outpatient cardiac rehabilitation program (control group). A 4 weeks of 12 outpatient cardiac rehabilitation sessions consisting of 3 sessions per week was provided to both the groups. Intervention group received standardized outpatient cardiac rehabilitation program along with power walking based on targeted heart rate and weekly steps, whereas control group received only standardized outpatient cardiac rehabilitation program based on American College of Sports Medicine (ACSM) Guidelines. The investigators measured Quality Of Life (HRQoL) by HeartQoL questionnaire, Exercise Capacity by 6 min walk test (6MWT), Left ventricle Ejection fraction (LVEF) using Echocardiogram, Metabolic Equivalent Task (MET'S) using Symptom-limited exercise stress test and Average number of steps walked daily using step up smartphone Pedometer App.

Conditions

Heart Diseases, Ischemic; Coronary Artery Disease; Coronary Arteriosclerosis; Coronary Syndrome; Coronary Disease

Keywords

cardiac rehabilitation; coronary angioplasty; power walking; heart quality of life; metabolic equivalents task

Outcome Measures

Primary Outcomes (1)

• Heart Quality of Life questionnaire global scores

  HeartQoL questionnaire has 14-items with two subscales consisting of 10 and 4 -item of physical and emotional subscales respectively. Subscale scores are summarised to global scores. Standard deviation scores specific to population mean were used for statistical analysis.

  From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session

Secondary Outcomes (4)

• Six Minute Walk Test (6MWT) distance in meters

  From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session

• Percentage of Left ventricle Ejection fraction (LVEF) i.e., Percentage of blood pumped out of left ventricle during each contraction.

  From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session

• Walking steps per day measured by pedometer

  From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session

• Energy expenditure measured in Metabolic equivalent of task (MET)

  From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session

Study Arms (2)

Power walking group

EXPERIMENTAL

Exercise in the form of Power walking at hospital for 10-20 minutes on treadmill with various exercise intensities. Weekly Steps at home 30 minutes walking with target to reach 1000 steps daily. Standardised Outpatient Cardiac Rehabilitation based on ACSM Guidelines where provided for four weeks. The program consisted of warm up, aerobics, strengthening and cool down exercises based on ACSM Guidelines described in Table 1 (Deborah, Jonathan, Gary \& Meir, 2018).

Behavioral: Power walking; Behavioral: Standardised outpatient cardiac rehabilitation

Standardised outpatient cardiac rehabilitation group

ACTIVE COMPARATOR

Standardised Outpatient Cardiac Rehabilitation based on ACSM Guidelines where provided for four weeks. The program consisted of warm up, aerobics, strengthening and cool down exercises based on ACSM Guidelines described in Table 1 (Deborah, Jonathan, Gary \& Meir, 2018).

Behavioral: Standardised outpatient cardiac rehabilitation

Interventions

Power walking BEHAVIORAL

Exercise in the form of Power walking at hospital for 10-20 minutes on treadmill with various exercise intensities. Weekly Steps at home 30 minutes walking with target to reach 1000 steps daily. It is a form of exercise where active upper body movement is performed along with usual walking. It is a fast walking exercise done at a speed of 6 to 8 km/h. During power walking the back is kept straight with the centre of gravity moving from heal, sole, and to hallux. There is active swing back and forth movement of elbow joint with 90 degrees of flexion while walking. Weekly protocol for power walking * Week 1 60-65 % of the target heart rate (THR) 5,000 to 7,499 steps/day * Week 2 65-70 % of the target heart rate (THR) 7,500 to 9,999 steps/day * Week 3 70-75 % of the target heart rate (THR) \>=10,000 steps/day * Week 4 75-80 % of the target heart rate (THR) \>12,500 steps per day

Power walking group

Standardised outpatient cardiac rehabilitation BEHAVIORAL

Standardised Outpatient Cardiac Rehabilitation based on ACSM Guidelines the intervention group received the following four weeks of intense training program

Power walking group; Standardised outpatient cardiac rehabilitation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those patients underwent coronary angioplasty and willing to participate
• Age between 18-70 years.
• Both the genders.
• Patients who completed not \< 2 week and not \>12 weeks post hospital discharge.
• Patients not limited to diabetes mellitus, controlled Hypertension, Hyperlipidemia and obese.
• Availability of smart phone.

You may not qualify if:

• Malignancy.
• Neurological disorders.
• Psychoneurotic disorders Causing deficit in functioning.
• Significant valvular diseases.
• Active pericarditis or myocarditis.
• Patient with complications related to angioplasty procedure.
• Severe orthostatic hypotension.
• Severe obstructive airway disease or any other chronic pulmonary disorder.
• Physically disabled patients.
• All Musculoskeletal disorders affecting movement of bilateral upper and lower limbs while walking at a faster speed of 6 to 8 km/h (47)
• Patients contraindicated for exercises testing and training.
• Severe uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg).

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, United Arab Emirates

Location

Related Links

• Physiotherapy research international, issue 26(4), e1919, 2021

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease; Angina, Unstable; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kumaraguruparan Gopal, Ph.D

  Gulf Medical University

  PRINCIPAL INVESTIGATOR

• Ramprasad M, Ph.D

  Gulf Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For each participant were blinded till allocation of treatment. Investigator was also blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 4-Week, Single-Blind, Parallel-Group Study

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 30, 2020
• Study Start: April 7, 2020
• Primary Completion: September 10, 2020
• Study Completion: September 13, 2020
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)