Eccentric Resistance Training Among Individuals With Chronic Heart Failure

Effects of Eccentric Resistance Training on Ventricle Functions and Aerobic Capacity Among Individuals With Chronic Heart Failure

To determine the effects of eccentric resistive training on ventricle functions and aerobic capacity as compared to a resistance and aerobic training among Heart failure (HF)

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Eccentric Resistive Training + Aerobic training Group; Other: Resistance Training + Aerobic training Group; Other: Aerobic training Group

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Iqbal Tariq, PhD*; Phone Number: +923338236752; Email: iqbal.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Pakistan Railway Hospital
      • Contact: Muhammad Iqbal Tariq, PhD*; Phone Number: +923338236752; Email: iqbal.tariq@riphah.edu.pk
      • Principal Investigator: Iqbal Tariq, PhD*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient able to safely perform lower limb exercise will be check by six- minute walk test (6 MWT)
• Diagnosis of Chronic HF and currently on optimal medical therapy

Exclusion Criteria:

• Already participating in cardiac rehabilitation

  • New York Heart Association (NYHA) Classification of HF class IV HF symptoms
  • Co-existent other disease such as asthma/ COPD/interstitial lung disease.
  • Symptomatic Second degree or third degree heart block.
  • ECG with uncontrolled ventricular arrhythmia
  • limited Exercise ability due to neurologic or orthopedic impairments of the legs (will cross-check with 6 MWT)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eccentric Resistive Training + Aerobic training Group	Other: Eccentric Resistive Training + Aerobic training Group; Eccentric Resistive training includes upper limb (biceps and triceps) and lower limb large muscle training (quadriceps and hamstrings) 2 sets of 12 repetitions (reps) for each group of muscles in lengthened position for eccentric training in approx. 20 minutes (min). Intensity will be based on 1 repetition maximum (1RM) starting from 20% of (1RM) and its intensity in percentage will be progress by 10% after every two weeks. Stair descending training and squatting position and eccentric hamstring curls with weights at ankle for lower limb eccentric training progressive as per tolerance in response to modified Borg scale (with cut off of showing dyspnea of 4 somewhat hard) and Numeric Pain rating scale (with cut off of showing 7 on scale, crossing moderate pain) . (approx. 20 min). + Aerobic training as a control will be given to this group as well for approximately 30 minutes per session.
Active Comparator: Resistance Training + Aerobic training Group	Other: Resistance Training + Aerobic training Group; Resistive training (concentric) includes Upper limb (biceps and triceps) and lower limb large muscle training (quadriceps and hamstrings), 2 sets of 12 reps for each group of muscles in approx. 30 min. Intensity will be based on 1 repetition maximum (1RM) starting from 20% of (1RM) and its intensity in percentage will be progress by 10% after every two weeks. Stair climbing training and quadriceps training + standing hamstring curls with weight at ankle for lower limb concentric training progressive as per tolerance in response to modified Borg scale (with cut off of showing dyspnea of 4 somewhat hard) and Numeric Pain rating scale (with cut off of showing 7 on scale, crossing moderate pain) + Aerobic training as a control will be given to this group as well for approximately 30 minutes per session.
Active Comparator: Aerobic training Group	Other: Aerobic training Group; Aerobic training as a control will be given to this group as well for approximately 60 minutes per session. Aerobic training exercise will be completed via a ergometer/stationary cycle; type will be continuous aerobic exercise and intensity of 60% of max HR (or peak VO2) in HF individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricle Functions	Changes from the baseline will be measured. Doppler resting echocardiography will be performed to measure ventricle functions. Standard views, including the parasternal long-axis, short-axis at the papillary muscle level, and apical 4- and 2-chamber views will be recorded. Left ventricular ejection fraction (LVEF) and end systolic and end-diastolic diameters (LVESD and LVEDD) will be measured using formula (Tiecholz formula i-e spherical volume of the heart multiplied by a correction factor). Any structural changes will also be recorded.	12 week
Aerobic Capacity	Changes will be measured at baseline, 4th week, 8th week and 12th week. The 6-min walk test provides an indirect measure of cardiovascular functional/aerobic capacity. Six Minute Walk test (6MWT) will be used to assess the functional capacity of the individuals with HF. The subjects will be instructed to walk for 6 minutes at a given time along a 30-m line at an interval of 1.5 m in an outdoor corridor, and the distance walked will be recorded in meters. The participants will be encouraged to continue walking as fast as possible. Then a generalized equation will be used to predict peak VO2 from 6 minute walk distance (6MWD) with the help of formula. Mean Peak VO2 (ml/kg/Mean) = 4.948 + 0.023 *Mean 6MWD (meters)	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (Minnesota Living with Heart Failure Questionnaire)	Changes from the baseline will be measured. Quality of life will be measured through Minnesota Living with Heart Failure Questionnaire (MLHFQ). It is one of the most widely used health-related quality of life questionnaires for individuals with HF. It provides scores for two dimensions, physical and emotional, and a total score. The MLHFQ is a self-administered, 21-item disease-specific instrument for individuals with HF. 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).	12 week
Strength	Changes will be measured at baseline, 4th week, 8th week and 12th week. Maximum muscle strength of the all major muscles biceps, triceps, quadriceps and hamstring, will be measured in sitting position with (MicroFET2 Digital Handheld Dynamometer muscle tester).	12 week
Maximal strength of respiratory muscles	Changes will be measured at baseline, 4th week, 8th week and 12th week. Maximum Inspiratory pressure (MIP) and Maximal Expiratory pressure (MEP) will be assessed through a handheld mouth pressure meter.	12 week
Forced Expiratory Volume in 1 second (FEV1)	Changes will be measured at baseline, 4th week, 8th week and 12th week, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters	12 week
Forced vital Capacity (FVC)	Changes will be measured at baseline, 4th week, 8th week and 12th week, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters	12 week
Peak Expiratory Flow (PEF)	Changes will be measured at baseline, 4th week, 8th week and 12th week, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.	12 week
Cardiac Risk Factors - Blood Pressure	Changes from the Baseline, Blood pressure (Bp) (both systolic/diastolic) will be measured in mmHg. It will be measured manually through sphygmomanometer by trained assessor in sitting position at baseline and at end of training on each week (for safety check).	12 week
Cardiac Risk Factors - Body mass index	Changes will be measured at baseline, 6th week and at 12th week. Weight in kilograms (kg) and Height in meters (m) will be combined to report BMI in kg/m^2 to measure the Body mass index	12 week
Cardiac Risk Factors - Lipid profile	Changes form the baseline, The lipid profile includes total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG). All units are in mmol/L.	12 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation (SpO2)	Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it. It will also be measured on each week (for safety check)	12 week
Change in heart rate variability (HRV)	HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar belt) during 6 MWT. It will be assessed at baseline, 4 th week, 8th week and at 12th week.	12 week
Modified Borg Dyspnoea Scale	Changes from baseline will be measured, It is most commonly used to assess symptoms of breathlessness. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal. It will be assess while participants doing 6 MWT.	12 week
Fatigue Severity Scale (FSS)	Changes from the baseline Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on you. The FSS is a short questionnaire that requires you to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. It will be assess while participants doing 6 MWT.	12 week
Adverse events	The number of adverse events resulting from the intervention will be noted.	12 week
Change in medication	Any reporting on hospitalization, visits to cardiologist/medical specialist and any change in medication will be recorded on questionnaire.	12 week
Adherence to the program	proportion % of the 36 potential sessions of adherent patients will be estimated in each of the periods followed.	12 week
Satisfaction score	Patient Assessment of Chronic Illness Care (PACIC) is a psychometrically validated scale, which could serve as a useful tool to assess patient satisfaction with Cardiac Rehabilitation. It is a 22-item self-measurement of how well patients perceive their chronic condition(s) are being managed by their health care team. Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "None of the time" and 5 signifying "Always". the overall PACIC score is calculated by averaging scores across all 20 items. Higher scores denote greater satisfaction.	12 week
Thigh circumference	Changes will be measured at baseline, 6th week and at 12th week. Thigh circumference (TC) will be measured using a tape measure in centimeter at the mid-trochanterion tibiale lateral site perpendicular to the longitudinal axis while the subject was standing.	12 week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University; Study Chair: Arshad Nawaz Malik, PhD, Riphah International University; Study Chair: Shane Patman, PhD, University of Notre Dame Australia

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ISB/REC/PhD/01199 Iqbal Tariq

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