search
Back to results

Eccentric Resistance Training Among Individuals With Chronic Heart Failure

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Eccentric Resistive Training + Aerobic training Group
Resistance Training + Aerobic training Group
Aerobic training Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pakistan Railway HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Eccentric Resistive Training + Aerobic training Group

Resistance Training + Aerobic training Group

Aerobic training Group

Arm Description

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

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).
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).
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.
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
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
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.
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).
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
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.

Full Information

First Posted
September 5, 2023
Last Updated
September 26, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT06032780
Brief Title
Eccentric Resistance Training Among Individuals With Chronic Heart Failure
Official Title
Effects of Eccentric Resistance Training on Ventricle Functions and Aerobic Capacity Among Individuals With Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Group allocation will be kept blinded to the assessor and to the treatment provider (trained physical therapist).
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eccentric Resistive Training + Aerobic training Group
Arm Type
Experimental
Arm Title
Resistance Training + Aerobic training Group
Arm Type
Active Comparator
Arm Title
Aerobic training Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Eccentric Resistive Training + Aerobic training Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance Training + Aerobic training Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic training Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventricle Functions
Description
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.
Time Frame
12 week
Title
Aerobic Capacity
Description
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)
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Quality of life (Minnesota Living with Heart Failure Questionnaire)
Description
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).
Time Frame
12 week
Title
Strength
Description
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).
Time Frame
12 week
Title
Maximal strength of respiratory muscles
Description
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.
Time Frame
12 week
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
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
Time Frame
12 week
Title
Forced vital Capacity (FVC)
Description
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
Time Frame
12 week
Title
Peak Expiratory Flow (PEF)
Description
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.
Time Frame
12 week
Title
Cardiac Risk Factors - Blood Pressure
Description
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).
Time Frame
12 week
Title
Cardiac Risk Factors - Body mass index
Description
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
Time Frame
12 week
Title
Cardiac Risk Factors - Lipid profile
Description
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.
Time Frame
12 week
Other Pre-specified Outcome Measures:
Title
Oxygen Saturation (SpO2)
Description
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)
Time Frame
12 week
Title
Change in heart rate variability (HRV)
Description
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.
Time Frame
12 week
Title
Modified Borg Dyspnoea Scale
Description
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.
Time Frame
12 week
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
12 week
Title
Adverse events
Description
The number of adverse events resulting from the intervention will be noted.
Time Frame
12 week
Title
Change in medication
Description
Any reporting on hospitalization, visits to cardiologist/medical specialist and any change in medication will be recorded on questionnaire.
Time Frame
12 week
Title
Adherence to the program
Description
proportion % of the 36 potential sessions of adherent patients will be estimated in each of the periods followed.
Time Frame
12 week
Title
Satisfaction score
Description
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.
Time Frame
12 week
Title
Thigh circumference
Description
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.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Iqbal Tariq, PhD*
Phone
+923338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arshad Nawaz Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shane Patman, PhD
Organizational Affiliation
University of Notre Dame Australia
Official's Role
Study Chair
Facility Information:
Facility Name
Pakistan Railway Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Phone
+923338236752
Email
iqbal.tariq@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Iqbal Tariq, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Eccentric Resistance Training Among Individuals With Chronic Heart Failure

We'll reach out to this number within 24 hrs