NCT06032780

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

September 5, 2023

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Quality of life (Minnesota Living with Heart Failure Questionnaire)

    12 week

  • Strength

    12 week

  • Maximal strength of respiratory muscles

    12 week

  • Forced Expiratory Volume in 1 second (FEV1)

    12 week

  • Forced vital Capacity (FVC)

    12 week

  • +4 more secondary outcomes

Other Outcomes (9)

  • Oxygen Saturation (SpO2)

    12 week

  • Change in heart rate variability (HRV)

    12 week

  • Modified Borg Dyspnoea Scale

    12 week

  • +6 more other outcomes

Study Arms (3)

Eccentric Resistive Training + Aerobic training Group

EXPERIMENTAL
Other: Eccentric Resistive Training + Aerobic training Group

Resistance Training + Aerobic training Group

ACTIVE COMPARATOR
Other: Resistance Training + Aerobic training Group

Aerobic training Group

ACTIVE COMPARATOR
Other: Aerobic training Group

Interventions

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.

Eccentric Resistive 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.

Resistance Training + 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.

Aerobic training Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Chronic HF and currently stable with optimal medical therapy
  • Chronic Heart failure with ejection fraction \> 30 %
  • Patient able to safely perform lower limb exercise will be check by six- minute walk test (6 MWT)

You may not qualify if:

  • Those Heart failure patient whose are in acute phase or planed for any immediate medical intervention
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

SUSPENDED

Rawalpindi Institute of Cardiology

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Arshad Nawaz Malik, PhD

    Riphah International University

    STUDY CHAIR
  • Shane Patman, PhD

    University of Notre Dame Australia

    STUDY CHAIR

Central Study Contacts

Muhammad Iqbal Tariq, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Group allocation will be kept blinded to the assessor and to the treatment provider (trained physical therapist).
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

September 20, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations