Eccentric Resistance Training Among Individuals With Chronic Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032780
• Other study ID #: ISB/REC/PhD/01199 Iqbal Tariq
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Riphah International University
• Contact: Muhammad Iqbal Tariq, PhD*
• Phone: +923338236752
• Email: iqbal.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	Pakistan Railway Hospital	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
Other	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
Other	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
Other	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
Other	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
Other	Adverse events	The number of adverse events resulting from the intervention will be noted.	12 week
Other	Change in medication	Any reporting on hospitalization, visits to cardiologist/medical specialist and any change in medication will be recorded on questionnaire.	12 week
Other	Adherence to the program	proportion % of the 36 potential sessions of adherent patients will be estimated in each of the periods followed.	12 week
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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