NCT07062874

Brief Summary

This study explores the effects of combined aerobic and resistance exercise in patients with non-ischemic dilated cardiomyopathy (NIDCM). In a six-week randomized clinical trial with 66 participants, both exercise groups-combined and aerobic-only-showed significant improvements in exercise capacity, functional independence, dyspnea, and blood pressure. However, no significant difference was found between the two groups. The study concludes that both exercise approaches are effective, but longer studies are needed to determine if combined training offers added benefits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 3, 2025

Last Update Submit

July 11, 2025

Conditions

Keywords

Cardiomyopathy, Dyspnea, Exercise, Functional Independence, NIDCM.

Outcome Measures

Primary Outcomes (2)

  • Functional Independence Measure (FIM) questionnaire

    Assesses level of functional independence across self-care, mobility, communication, and social cognition.

    Baseline and 6 weeks

  • VO₂ Max (Maximum Oxygen Consumption)

    Measured using Graded Exercise Test (GXT) to assess cardiovascular fitness.

    Baseline and 6 weeks.

Secondary Outcomes (2)

  • Modified Borg Dyspnea Scale

    Baseline and 6 weeks.

  • Blood Pressure (Systolic and Diastolic)

    Baseline and 6 weeks.

Study Arms (2)

Combined Aerobic and Resistance Exercise:

EXPERIMENTAL

Participants performed aerobic training three times a week for six weeks. Each session included a 10-minute warm-up, 30-minute main aerobic activity (60-85% of heart rate reserve using the Karvonen formula), and 10-minute cool-down. Additionally, they performed resistance exercises for upper and lower extremities using TheraBands, 8-10 sets covering major muscle groups, three times a week.

Behavioral: Combined Aerobic and Resistance ExerciseBehavioral: Aerobic Exercise Only

Aerobic Exercise Only

ACTIVE COMPARATOR

Participants followed the same aerobic training protocol as Group A. No resistance training was included. Sessions also occurred three times a week for six weeks, with similar warm-up, active, and cool-down phases.

Behavioral: Aerobic Exercise Only

Interventions

Participants received supervised exercise training 3 times per week for 6 weeks. Each session included a 10-minute warm-up (walking at 1.5 km/h), a 30-minute aerobic phase at 60-85% heart rate reserve (calculated using the Karvonen formula), and a 10-minute cool-down (walking at 1 km/h). In addition, participants performed resistance training for upper and lower extremities using TheraBands, with 8-10 sets targeting major muscle groups.

Also known as: Resistance training
Combined Aerobic and Resistance Exercise:

Participants followed the same aerobic training protocol as the experimental group-3 sessions per week for 6 weeks, with 10-minute warm-up, 30-minute aerobic exercise (60-85% HRR), and 10-minute cool-down. No resistance training was provided.

Aerobic Exercise OnlyCombined Aerobic and Resistance Exercise:

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female Age 40 to 60
  • Left ventricular ejection fraction \<50%

You may not qualify if:

  • Patients diagnosed with valvular heart disease, supraventricular arrhythmias, congenital heart disease were excluded.
  • Neuromuscular diseases such as stroke, Parkinson.
  • Underlying pulmonary disease
  • Impaired cognitive function (14)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arjumand

Lahore, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

CardiomyopathiesDyspneaMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Arjumand Bano, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

July 28, 2025

Primary Completion

September 28, 2025

Study Completion

October 10, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations