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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04937231
Other study ID # REC/00880 Mahnoor Shabbir
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria: - Heart failure patients with ejection fraction greater than 35% Exclusion Criteria: - Patients with unstable angina - Patients who had severe pain in the lower limbs - Patients with Blood pressure greater than 190/120mmHg were excluded - Patients who had positive contraindication for cardiac rehabilitation were not admitted in this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercises
For Week 1 and 2 : Treadmill 3-5days/weeks Intensity: 50-70 vo2 peak Or HRR 60-80% Duration of 10-20 minutes For Week 3 and 4; Cycle ergometer 3-5days/weeks Intensity: 50-70 vo2 peak Or HRR 60-80% Duration of 30-40 minutes
Resistance exercises
For Week 1 and 2; 2 x 10 rep (unilateral leg press) 4x 12 reps (Bilateral leg press 1 x 8 rep ( unilateral arm curls For Week 3 and 4; 1 x 10 reps Shoulder press 1 x15 rep Bilateral knee extension 1 x 10 reps Bilateral arm curls
Combined training
For Week 1 and 2; Aerobic exercise on Treadmill along with dumbbell to perform upper limb exercises (biceps curls, side curls extensions, upright row, back fly) and used Thera band to perform lower limb exercises for 10-20 minutes For Week 3 and 4; Aerobic exercise on Treadmill along with dumbbell and Thera band to perform upper limb and lower limb exercises for 30-40 minutes

Locations

Country Name City State
Pakistan Rawalpindi Institute of Cardiology Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. Changes from the Baseline will be measured. 4th week
Primary Minnesota living with heart failure questionnaire Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered, 21-item disease-specific instrument for patients with heart failure. MLHFQ is an instrument which has been widely used to assess quality of life among heart failure patients. Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The MLHFQ has two domains; physical domain (eight items, score range from 0 to 40) and emotional domain (five items, score range from 0 to 25). Changes from the Baseline will be measured 4th week
Primary 6 Min walk test (Distance in meters) Changes from the baseline, 6 Min Walk Distance (6 MWD) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support. 4th Week
Primary Peak VO2 with formula A generalized equation can be used to determined Peak rate of oxygen consumption (peak VO2). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is:
Mean peak VO2(ml/kg/mins) = 4.948 + 0.023*Mean 6 MWD (meter) Changes From the Baseline will be measured.
4th Week
Primary Heart Rate/Pulse Rate Changes from baseline, Pulse rate was measured per minute through pulse oximeter. Crossly it was measure by Chest belt (Polar Heart Rate monitors). Changes from the Baseline will be measure. 4th Week
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