NCT04937231

Brief Summary

To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 15, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

June 15, 2021

Last Update Submit

October 19, 2021

Conditions

Keywords

Aerobic ExercisesResistance TrainingCombined Training

Outcome Measures

Primary Outcomes (5)

  • Hospital Anxiety and Depression Scale

    Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. Changes from the Baseline will be measured.

    4th week

  • Minnesota living with heart failure questionnaire

    Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered, 21-item disease-specific instrument for patients with heart failure. MLHFQ is an instrument which has been widely used to assess quality of life among heart failure patients. 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). Changes from the Baseline will be measured

    4th week

  • 6 Min walk test (Distance in meters)

    Changes from the baseline, 6 Min Walk Distance (6 MWD) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.

    4th Week

  • Peak VO2 with formula

    A generalized equation can be used to determined Peak rate of oxygen consumption (peak VO2). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is: Mean peak VO2(ml/kg/mins) = 4.948 + 0.023\*Mean 6 MWD (meter) Changes From the Baseline will be measured.

    4th Week

  • Heart Rate/Pulse Rate

    Changes from baseline, Pulse rate was measured per minute through pulse oximeter. Crossly it was measure by Chest belt (Polar Heart Rate monitors). Changes from the Baseline will be measure.

    4th Week

Study Arms (3)

Aerobic exercises

EXPERIMENTAL

Treadmill and Cycle ergometer

Other: Aerobic exercises

Resistance exercises

EXPERIMENTAL

unilateral leg press, Bilateral leg press, unilateral arm curls

Other: Resistance exercises

Combined training

EXPERIMENTAL

Treadmill and Cycle ergometer along with resistive Training

Other: Combined training

Interventions

For Week 1 and 2 : Treadmill 3-5days/weeks Intensity: 50-70 vo2 peak Or HRR 60-80% Duration of 10-20 minutes For Week 3 and 4; Cycle ergometer 3-5days/weeks Intensity: 50-70 vo2 peak Or HRR 60-80% Duration of 30-40 minutes

Aerobic exercises

For Week 1 and 2; 2 x 10 rep (unilateral leg press) 4x 12 reps (Bilateral leg press 1 x 8 rep ( unilateral arm curls For Week 3 and 4; 1 x 10 reps Shoulder press 1 x15 rep Bilateral knee extension 1 x 10 reps Bilateral arm curls

Resistance exercises

For Week 1 and 2; Aerobic exercise on Treadmill along with dumbbell to perform upper limb exercises (biceps curls, side curls extensions, upright row, back fly) and used Thera band to perform lower limb exercises for 10-20 minutes For Week 3 and 4; Aerobic exercise on Treadmill along with dumbbell and Thera band to perform upper limb and lower limb exercises for 30-40 minutes

Combined training

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients with ejection fraction greater than 35%

You may not qualify if:

  • Patients with unstable angina
  • Patients who had severe pain in the lower limbs
  • Patients with Blood pressure greater than 190/120mmHg were excluded
  • Patients who had positive contraindication for cardiac rehabilitation were not admitted in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawalpindi Institute of Cardiology

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

October 15, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations