Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Aerobic exercises; Other: Resistance exercises; Other: Combined training

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • Rawalpindi Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercises; Treadmill and Cycle ergometer	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
Experimental: Resistance exercises; unilateral leg press, Bilateral leg press, unilateral arm curls	Other: 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
Experimental: Combined training; Treadmill and Cycle ergometer along with resistive Training	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Resistance Training; Combined Training; Aerobic Exercises
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: REC/00880 Mahnoor Shabbir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No