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Heart Diseases, IschemicPowerWalkNCT04610060

Power Walking in Cardiac Patients Who Underwent Post-coronary Angioplasty

A study testing Power walking and Standardised outpatient cardiac rehabilitation in people with Heart Diseases, Ischemic and Coronary Artery Disease, run by Gulf Medical University at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Power walking and Standardised outpatient cardiac rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Arab Emirates
Study dates
7 Apr 2020to 13 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Malignancy.
  • Neurological disorders.
  • Psychoneurotic disorders Causing deficit in functioning.
  • Significant valvular diseases.
  • Active pericarditis or myocarditis.
  • Patient with complications related to angioplasty procedure.
Show all 12Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • Gulf Medical University

    Ajman

Other trials in United Arab Emirates

About this study

Official title: Effectiveness of Standardized Outpatient Cardiac Rehabilitation Program Combined With Power Walking on Quality of Life and Exercise Capacity in Patients With Post-coronary Angioplasty: A Pragmatic Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

Approximately 17.8 million worldwide deaths per year are due to cardiovascular disease (CVD). Arab countries are at higher risk of CVD in which middle income countries are mostly at burden. "The threshold for cardiac arrests and cardiovascular disease (CVD) worldwide is 65 years, while people in the UAE are suffering from the CVD at the age of 45" reported by Emirates Cardiac Society. One of the most common causes of cardiovascular deaths is coronary artery disease (CAD). Coronary angioplasty one of the most common non-surgical approach for the treatment of ischemic coronary artery disease. It is widely accepted that cardiac rehabilitation can be beneficial for patients with heart diseases. Most of the patients won't achieve adequate functional improvement, if rehabilitation exercises are not done on regular basis post-coronary angioplasty.

In cardiac rehabilitation (CR) programs, psychosocial function and the assessment of quality of life (QOL) are the major objective parameters commonly used by researchers. Physical activity and emotional status influence health related quality of life (HRQOL) in patient underwent coronary angioplasty. It is important to find effectiveness of CR on health related quality of life (HRQOL). Studies has shown that tailored exercise training helped to improve Left Ventricle Ejection Fraction (LVEF) in patients post coronary angioplasty. A systematic review highlighted the effectiveness of using 6MWT to show improvement of functional capacity in patients undergoing cardiac rehabilitation.

It is well known that walking exercise reduces cardiovascular disease-related mortality and predicts longevity in patients with established CAD. One of the integral components of cardiac rehabilitation is treadmill walking. A meta-analysis demonstrated that physical activity could be enhanced in patients with the use of pedometer. Recent evidence shows that smartphone apps are effective at promoting physical activity. Studies also shows that smartphone Apps are more accurate in tracking steps as compared to fitness trackers.

Power walking is an effective part of phase II cardiac rehabilitation. Running is preferred over walking since oxygen consumption while running is less as compared to walking.

It was reported that up to 1 year, cardiac rehabilitation improves QOL in patients with acute myocardial infarction (AMI) or revascularization procedures. Four weeks of short CR course provides better attendance, improvement in quality of life and exercise capacity.

Accordingly, the current study was conducted for 4 weeks, a shorter period of rehabilitation and documented the effectiveness on cardiac fitness including health related quality of life, functional exercise capacity, ejection fraction and metabolic equivalent task (MET's) of patients with post angioplasty.

Although the advantages of CR are well known to most of the physicians, still one third of the patients do not receive CR post coronary angioplasty due to poor referral trends. Higher rates of quality-of-care measures were found among patients who were referred for CR compared to those who were not referred. Post coronary angioplasty patients need to continue with cardiac rehabilitation in a progressive manner to attain the overall improvement. In a comparative study where 5 and 39 CR programs participated from Arab countries and Canada respectively showed that in Arab countries CR programs are very limited. Recent statistics in UAE has shown that 30% deaths are due to cardiovascular diseases, 30-70% population has cardiovascular diseases or are at risk and 37% population do not exercise and are physical inactive.

The concept is very clear that significant number of eligible patients with cardiac conditions is not referred for outpatient CR. Although most patients post coronary angioplasty are encouraged by cardiologist to gradually increase their activity levels, limited data are available on the amount of physical and walking activity and regular aerobic exercises done by patients with post coronary angioplasty at phase II CR.

Power walking has an advantage that it consumes 55% more energy in comparison to just walking alone or running at a speed of 6 to 8 km/h, while being at a lower intensity. Despite the advantages of power walking, the exercise effects have not been reported in cardiac rehabilitation programs.

This study will help to fulfill great need for referral and awareness of out patient cardiac rehabilitation by proving outcomes of standardized outpatient cardiac rehabilitation program. The investigators utilized power walking along with standardized cardiac rehabilitation to find effectiveness on health related quality of life, functional exercise capacity, ejection fraction and metabolic equivalent task (MET's) of patients with post coronary angioplasty. Henceforth, the need for research is to prove the effectiveness of cardiac rehabilitation in UAE population.

Being tested
Power walking, Standardised outpatient cardiac rehabilitation
Keywords
cardiac rehabilitation, coronary angioplasty, power walking, heart quality of life, metabolic equivalents task
Medical subject headings
Myocardial Ischemia, Coronary Artery Disease, Angina, Unstable, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Power walkingBehavioural

    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
  • Standardised outpatient cardiac rehabilitationBehavioural

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

Study groups in NCT04610060
Study groupRoleWhat they receive
Power walking groupExperimentalExercise 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).
Receives: Behavioral: Power walking; Behavioral: Standardised outpatient cardiac rehabilitation
Standardised outpatient cardiac rehabilitation groupActive comparatorStandardised 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).
Receives: Behavioral: Standardised outpatient cardiac rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Six Minute Walk Test (6MWT) distance in meters

    The outcome of the 6MWT is the 6-minute walk distance (6MWD) measured in meters.

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

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

    Percentage of blood pumped out of left ventricle during each contraction measured by echocardiogram.

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

  3. Walking steps per day measured by pedometer

    A digital mobile application was used to record steps taken on day by day basis and cumulative average until 4th week was calculated

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

  4. Energy expenditure measured in Metabolic equivalent of task (MET)

    MET was calculated based on symptom-limited exercise stress test, i.e, Bruce protocol.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start7 Apr 2020
  3. Primary completion10 Sep 2020
  4. Study completion13 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A 4-Week, Single-Blind, Parallel-Group Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04610060
Sponsor's protocol ID
INT/COHS/PG/015-2020
Acronym
PowerWalk
Status last verified
Oct 2022
First submitted
25 Sep 2020
Last updated
18 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Power walking and Standardised outpatient cardiac rehabilitation in people with Heart Diseases, Ischemic and Coronary Artery Disease, run by Gulf Medical University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Quality of Life questionnaire global scores (time frame: From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.

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