Heart FailureNCT04937231
Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
A study testing Aerobic exercises, Resistance exercises and Combined training in people with Heart Failure, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aerobic exercises, Resistance exercises and Combined training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure patients with ejection fraction greater than 35%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, 44000
About this study
To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Aerobic exercises, Resistance exercises, Combined training
- Keywords
- Aerobic Exercises, Resistance Training, Combined Training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesOther
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
Resistance exercisesOther
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
Combined trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercises | Experimental | Treadmill and Cycle ergometer Receives: Other: Aerobic exercises |
| Resistance exercises | Experimental | unilateral leg press, Bilateral leg press, unilateral arm curls Receives: Other: Resistance exercises |
| Combined training | Experimental | Treadmill and Cycle ergometer along with resistive Training Receives: Other: Combined training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
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.
Measured: 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.
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.
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start15 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937231
- Sponsor's protocol ID
- REC/00880 Mahnoor Shabbir
- Status last verified
- Oct 2021
- First submitted
- 15 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04937231
- Acronym / sponsor ID
- REC/00880 Mahnoor Shabbir
- Conditions
- Heart Failure
- Keywords
- Aerobic Exercises, Resistance Training, Combined Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises | Experimental | Other: Aerobic exercisesTreadmill and Cycle ergometer |
| Resistance exercises | Experimental | Other: Resistance exercisesunilateral leg press, Bilateral leg press, unilateral arm curls |
| Combined training | Experimental | Other: Combined trainingTreadmill and Cycle ergometer along with resistive Training |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure patients with ejection fraction greater than 35%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercisesFor 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 | Other | Aerobic exercises |
| Resistance exercisesFor 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 | Other | Resistance exercises |
| Combined trainingFor 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 | Other | Combined training |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: 4th week
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.
Minnesota living with heart failure questionnaire
Time frame: 4th week
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
6 Min walk test (Distance in meters)
Time frame: 4th Week
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.
Peak VO2 with formula
Time frame: 4th Week
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.
Heart Rate/Pulse Rate
Time frame: 4th Week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, MSCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercises, Resistance exercises and Combined training in people with Heart Failure, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: 4th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.