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Chronic Heart FailureNCT03615157

Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients

A study testing Exercise rehabilitation in people with Chronic Heart Failure, run by University of Sao Paulo at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
Exercise rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesBrazil
Study dates
15 Jan 2018to 15 Feb 2019
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic heart failure (functional class from NYHA II and III),
  • Left ventricle ejection fraction bellow or equal to 40%
  • Clinical stability during the last three months
  • Medical release for physical training after cardiopulmonary test

Who cannot join

  • Uncontrolled arrhythmia
  • Pulmonary artery systolic pressure > 35 mmHg by the echo doppler cardiogram,
  • Peripheral oxygen saturation < 92% in resting condition
  • Respiratory infection in the previous 30 days to the enrollment into the study
  • Cognitive, neurological or orthopedic limitations

Trial locations and contacts

2 sites in 1 country.

Naomi K Nakagawa, PhD contact

+551130618529

naomi.kondo@fm.usp.br

Geisa N Andrade contact

+5511993038655

geisandrade@usp.br

Brazil2 sites, 2 recruiting

  • School of Medicine, University of Sao Paulo

    São Paulo, São Paulo, 01246903

    NAOMI KONDO NAKAGAWA N KONDO, 11999450626, naomi.kondo@fm.usp.br

    Geisa N Andrade, BSc

    Recruiting

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012-909

    Iracema IK Umeda, PhD, +551150856304, iikumeda@usp.br

    Geisa N Andrade, +5511993038655, geisandrade@usp.br

    Recruiting

Other trials in Brazil

About this study

Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. In this way, home physical training may be a good alternative to patients who, for any reason, cannot perform supervised training. Objective: To asses the effects of a home-based training program on functional capacity, sedentary lifestyle and quality of life of patients with chronic HF compared to supervised training.

Read the detailed description

After agreement with the written informed consent, subjects with heart failure (left ventricle ejection fraction bellow or equal 40%) will be included in this study. They will be randomized in two groups: Home-based and Supervised exercise groups. The two groups will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. All volunteers will be assessed at baseline and after twelve weeks of intervention. Peripheric and respiratory muscle strength as well the 6MW analyses were assessed also at 4 and 8 weeks after baseline.

Being tested
Exercise rehabilitation
Keywords
Home-based exercise, Functional capacity, Chronic Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise rehabilitationOther

    Also called Aerobic and resistance training

    Patients will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. They will be randomized in two groups: Home-based and Supervised.

Study groups in NCT03615157
Study groupRoleWhat they receive
Home-based exercise rehabilitationExperimentalPatients will be submitted to a 12-weeks training program, with walking at 60-70% of heart rate reserve monitored by a heart rate monitor (30 minutes/session for 5 days/week) and peripheral muscle training including upper and lower limbs (50% of the 1-maximum repetition test)
Receives: Other: Exercise rehabilitation
Supervised exercise rehabilitationActive comparatorPatients will be submitted to a 12-weeks training program, with sessions (3 days/week) supervised by a physiotherapist, including cycling at 60-70% of heart rate reserve and peripheral muscle training of upper and lower limbs (50% of the 1-maximum repetition test)
Receives: Other: Exercise rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in peak oxygen uptake (ml/kg/min)

    Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.

    Measured: Baseline and after 12 weeks of exercise programs

Secondary outcomes (13)

  1. Incidence of cardiac events and arrhythmia

    By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs

    Measured: Baseline and after 12 weeks of exercise programs

  2. Changes in distance from the six minute walk test (6MW, m)

    Patients will be submitted to the 6MW accordingly to the American Thoracic guidelines to assess functional capacity using the six minute walk test

    Measured: Baseline and after 4, 8 and 12 weeks of exercise programs

  3. Changes in respiratory muscle strength (cmH2O)

    Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer

    Measured: Baseline and after 4, 8 and 12 weeks of exercise programs

  4. Changes in peripheral muscle strength (N) - Quadriceps mm

    Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA)

    Measured: Baseline and after 4, 8 and 12 weeks of exercise program

  5. Changes in peripheral muscle strength (kgf) - Hand grip

    Hand grip strength will be assessed by Jamar dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440)

    Measured: Baseline and after 4, 8 and 12 weeks of exercise programs

  6. Changes in daily physical activity and sedentary lifestyle

    Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on waist during 9 days to asses daily physical activity and sedentary lifestyle

    Measured: Baseline and after 12 weeks of exercise programs

  7. Changes in International Physical Activity Questionnaire (IPAQ)

    Patients will be classified as sedentary, irregularly active, active or very active according to Matsudo's Classification (2001)

    Measured: Baseline and after 12 weeks of exercise programs

  8. Changes in quality of life using SF-36

    Quality of life will be assessed by the Short Form-36 Questionnaire

    Measured: Baseline and after 12 weeks of exercise programs

  9. Changes in quality of life using MLHF

    Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire

    Measured: Baseline and after 12 weeks of exercise programs

  10. Changes in brain natriuretic peptide (BNP, pg/mL)

    A blood sample of 5 ml will be collected in a tube and BNP will be measured

    Measured: Baseline and after 12 weeks of exercise programs

  11. Changes in heart rate variability (HRV)

    HRV will be analysed from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland) during the 6MW

    Measured: Baseline and after 12 weeks of exercise programs

  12. Changes in sleep quality

    Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on wrist for nine days to asses Sleep quality. Furthermore, the Pittsburgh Sleep Quality Index will be used to classify patients as good or poor sleepers.

    Measured: Baseline and after 12 weeks of exercise programs

  13. Changes in daytime sleepiness

    Daytime sleepiness will be assessed by the Epworth Sleepiness Scale

    Measured: Baseline and after 12 weeks of exercise programs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2018
  2. Study start15 Jan 2018
  3. Primary completion15 Dec 2018 (estimated)
  4. Study completion15 Feb 2019 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants will be randomized in two groups: Home-based and Supervised exercise groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615157
Sponsor's protocol ID
CEP 411/14
Status last verified
Jul 2018
First submitted
30 Jul 2018
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: we will insert all individual data in a common website for research

Publications

  • Andrade GN, Umeda IIK, Fuchs ARCN, Mastrocola LE, Rossi-Neto JM, Moreira DAR, Oliveira PA, Andre CDS, Cahalin LP, Nakagawa NK. Home-based training program in patients with chronic heart failure and reduced ejection fraction: a randomized pilot study. Clinics (Sao Paulo). 2021 Jun 11;76:e2550. doi: 10.6061/clinics/2021/e2550. eCollection 2021.

    PubMed 34133657

Questions about this trial

What is this clinical trial studying?

A study testing Exercise rehabilitation in people with Chronic Heart Failure, run by University of Sao Paulo at 2 sites in Brazil.

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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Naomi K Nakagawa, PhD (+551130618529, naomi.kondo@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in peak oxygen uptake (ml/kg/min) (time frame: Baseline and after 12 weeks of exercise programs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615157, which also lists 1 linked publication.

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 3 Aug 2018.

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