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Chronic Heart FailureNCT03675113

Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure

A study testing Upper extremity aerobic exercise in people with Chronic Heart Failure, run by Gazi University at 2 sites in Turkey (Türkiye).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Heart failure is a cardiac structural or functional disorder that, despite normal filling pressures, leads to inability to deliver enough oxygen to meet the metabolic needs o tissue. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
Upper extremity aerobic exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesTurkey (Türkiye)
Study dates
5 Sep 2018to Dec 2020
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of chronic heart failure diagnosed at rest below 40% of the left ventricular ejection fraction and class 1-3 according to the New York Heart Association classification
  • Optimal medical treatment at least 30 days and clinically stable

Who cannot join

  • Patients with unstable angina pectoris
  • Decompensated heart failure
  • Primary pulmonary hypertension
  • Complex ventricular arrhythmia
  • Contraindication to cardiopulmonary exercise testing
  • Patients who have had myocardial ischemia in the past 3 months
Show all 16Show fewer
  • Ischemic cerebrovascular events
  • Second and third degree atrioventricular block
  • Thrombus detected in the left ventricle
  • Uncontrolled insulin dependent diabetes mellitus
  • Uncontrolled hypertension
  • Renal insufficiency
  • Acute infection
  • Aortic stenosis
  • Acute pulmonary embolism
  • Mental, musculoskeletal, neurological, or systemic illness that will prevent exercise.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Gazi University

    Ankara, Yenimahalle, 06500

  • Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

    Ankara, 06500

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Upper Extremity Aerobic Exercise Training on Exercise Capacity and Physical Activity Level in Patients With Chronic Heart Failure

Heart failure is a cardiac structural or functional disorder that, despite normal filling pressures, leads to inability to deliver enough oxygen to meet the metabolic needs o tissue. Heart failure is a serious chronic condition that affects a large proportion of the adult population in the world causing high mortality, leading to exercise intolerance and reduced health-related quality of life. Patients included in the cardiac rehabilitation program slow down disease progression, hospitalization decreases, quality of life improves and health expenditures decrease. Despite the frequent use of upper extremities in daily living activities, studies investigating the effect of upper extremity aerobic training on daily living activities, functional exercise capacity and other outcomes are limited. No studies have investigated the effect of upper extremity aerobic exercise training on physical activity level, functional and maximal exercise capacity and other measures in patients with heart failure.

Read the detailed description

It has been reported that exercise capacity in peak arm exercise is almost 30% lower in heart failure patients. For this reason intolerance to arm exercise is a significant problem in heart failure patients and may contribute to a decrease in performance in activities of daily living. Considering the fact that developments in these patients are caused by vasculature functional adaptation the extremity skeletal muscle and applied limbs, upper extremity exercises may be useful to reduce exercise intolerance during activities requiring continuous arm movement.

Being tested
Upper extremity aerobic exercise, Control Group
Keywords
upper extremity aerobic exercise, functional exercise capacity, maximal exercise capacity, respiratory endurance, quality of life, dyspnea, pulmonary function, fatigue, anxiety, depression
Medical subject headings
Dyspnea, Fatigue, Anxiety Disorders, Depression

What participants receive

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

  • Upper extremity aerobic exerciseOther

    Range of maximal heart rate will be followed by a polar band during supervised session each week.

    Aerobic exercise will be trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department.

  • Control GroupOther

    Deep breathing exercises combinated with arm movements

Study groups in NCT03675113
Study groupRoleWhat they receive
upper extremity aerobic groupExperimentalThe upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be 3 day per a week through 6-weeks.
Receives: Other: Upper extremity aerobic exercise
control groupSham comparatorDeep breathing exercises combination with arm movements will be given as a home program in the control group. Training duration will be 3 day per a week through 6-weeks.
Receives: Other: Control Group

What is being measured

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

  1. Maximal exercise capacity

    It will be evaluated using symptom limited cardiopulmonary exercise testing. The cardiopulmonary exercise test will be performed at a progressively increasing speed and grade

    Measured: Second day

Secondary outcomes (14)
  1. Pulmonary function

    Dynamic lung volume measurements will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.

    Measured: First day

  2. Respiratory muscle strength

    Maximal inspiratory and expiratory muscle strength will be evaluated a using mouth pressure device.

    Measured: First day

  3. Pulmonary muscle endurance

    It will be evaluated incremental threshold loading test, in which participants started an initial load of 30% of maximal inspiratory pressure with a 10% increment every 2 minutes.

    Measured: First day

  4. Peripheral muscle strength

    It will be evaluated using a portable hand held Dynamometer.

    Measured: First day

  5. Grip strength

    It will be evaluated using a grip dynamometer.

    Measured: First day

  6. Functional impairment due to dyspnea

    It will be evaluated with modified Medical Research Council Dyspnea Scale (MMRC). MMRC is a baseline assessment of functional impairment attributable to dyspnea from respiratory disease. modified Medical Research Council (mMRC) Dyspnea Scale, which consist of five-item scale based on a variety of physical activities that cause a feeling of dyspnea, was used to determine the severity of patients' shortness of breath. The participants read and chose the most appropriate scale option between 0 and 4 that best describes the degree of their pulmonary distress.

    Measured: First day

  7. Physical activity level

    Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.

    Measured: First day

  8. Functional exercise capacity

    Six minute pegboard and ring test (6-PBRT) was applied to assess the functional capacity of the upper limbs. Subjects are asked to move as many rings as possible in 6 minutes, and the score is the number of rings moved during the 6-minute period.

    Measured: First day

  9. Activity daily of living

    London Chest Activity Daily of Living Scale is a 15-item scale divided into 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items).The total score is calculated by summing the domains and ranges from 0 to 75, with higher values indicating more marked limitation in activity daily of living performance.

    Measured: Second day

  10. Quality of sleep

    Pittsburgh Sleep Quality Index (Turkish version) (PSQI) is a self-reported questionnaire. PSQI evaluates patients' sleep quality. The scale includes 24 questions overall, with 19 questions answered by the person him/ herself and the remaining 5 answered by his/her bed partner or roommate. The first 19 self-answered questions evaluate 7 subscales, subjective sleep quality, sleep latency, duration of sleep, routine sleep activity, sleep disorders, the use of drugs for sleeping, and daytime dysfunction. Each item in the scale is scored between 0 and 3 (no difficulty to severe difficulty). The sum of the 7 subscale scores gives the overall PSQI score. Lower scores show better sleep quality.

    Measured: Second day

  11. Fatigue

    Fatigue Severity Scale (Turkish version) - Fatigue Severity Scale (FSS) is a self-reported questionnaire. FSS evaluates patient's fatigue severity. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue).

    Measured: Second day

  12. Anxiety and depression

    Hospital Anxiety and Depression (Turkish version). The test used to determine the risk group of patients in terms of anxiety and depression and consists of 14 questions. Lowest score that patients can get from both subscales is 0, the highest score 21. The cut-off points for the Turkish version of the HAD scale were 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D).

    Measured: Second day

  13. Quality of life scale

    Minnesota Living with Heart Failure Questionnaire (MLHFQ) (Turkish version of scale) 21 items rated on six-point Likert scales, representing different degrees of impact of heart failure on Heart Related Quality of Life (HRQoL), from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25).

    Measured: Second day

  14. Dyspnea

    It will be evaluated modified Borg Scale. This modified 12-point scale consists (0, 0.5, 1-10) corresponds with increasing shortness of breath. Patients were asked to mark the most appropriate description or number of their shortness of breath at rest and during exercise.

    Measured: Second day

Timeline

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

  1. First posted18 Sep 2018
  2. Study start5 Sep 2018
  3. Primary completionJun 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: This study was a doctorate thesis and student changed the subject of her thesis.

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03675113
Sponsor's protocol ID
Gazi University 14
Status last verified
Oct 2020
First submitted
12 Sep 2018
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giannuzzi P, Temporelli PL, Corra U, Tavazzi L; ELVD-CHF Study Group. Antiremodeling effect of long-term exercise training in patients with stable chronic heart failure: results of the Exercise in Left Ventricular Dysfunction and Chronic Heart Failure (ELVD-CHF) Trial. Circulation. 2003 Aug 5;108(5):554-9. doi: 10.1161/01.CIR.0000081780.38477.FA. Epub 2003 Jul 14.

    PubMed 12860904
  • Ades PA, Keteyian SJ, Balady GJ, Houston-Miller N, Kitzman DW, Mancini DM, Rich MW. Cardiac rehabilitation exercise and self-care for chronic heart failure. JACC Heart Fail. 2013 Dec;1(6):540-7. doi: 10.1016/j.jchf.2013.09.002. Epub 2013 Oct 24.

    PubMed 24622007
  • Antunes-Correa LM, Kanamura BY, Melo RC, Nobre TS, Ueno LM, Franco FG, Roveda F, Braga AM, Rondon MU, Brum PC, Barretto AC, Middlekauff HR, Negrao CE. Exercise training improves neurovascular control and functional capacity in heart failure patients regardless of age. Eur J Prev Cardiol. 2012 Aug;19(4):822-9. doi: 10.1177/1741826711414626. Epub 2011 Jun 22.

    PubMed 21697210

Questions about this trial

What is this clinical trial studying?

A study testing Upper extremity aerobic exercise in people with Chronic Heart Failure, run by Gazi University at 2 sites in Turkey (Türkiye).

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 2 inclusion and 16 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: withdrawn, as of the sponsor's last update on 22 Oct 2020. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

Maximal exercise capacity (time frame: Second day). 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 NCT03675113, which also lists 3 linked publications.

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 22 Oct 2020.

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