NCT06481657

Brief Summary

Background: Physical training in patients with heart failure has been proven to reduce mortality and hospitalization rates, but many have difficulty performing an effort due to a lack of oxygen supply to the muscle and its fatigue. The effect of supplementing oxygen in a single effort was found to improve the level of oxygen reaching the muscle, the duration and intensity of the effort. The effect of supplemental oxygen during an exercise program in heart failure patients on exercise performance has not yet been examined. The aims of the study: 1. To test the effect of a training program with oxygen supplementation, on maximal and submaximal aerobic exercise, six-minute walk (6MWT) and quality of life in patients with heart failure. 2. Testing the effect of oxygen supplementation in a single effort on the lactate concentration and performance of the effort. Methods: 24 independent heart failure patients, without a decrease in saturation, with an ejection fraction \<50% were recruited for the study and were randomly divided into two groups, a training group with supplemental oxygen (O2) and a control group that trained without supplemental oxygen. Before and after a training program that lasted two months, the following were tested: maximal aerobic power, submaximal aerobic exercise time, 6MWT, disease severity according to the New York Heart Association - NYHA and quality of life according to the Kansas Questionnaire (KCCQ)). In addition, a single submaximal effort was performed at 80% of maximum heart rate with and without oxygen supplementation. Every 3 minutes the lactate concentration, heart rate and the difficulty of the effort were measured. To test the effect of the intervention on the outcome measures, a 2way ANOVA test was performed for repeated measurements. Importance of the study: The results of the study will make it possible to examine for the first time the effect and importance of oxygen supplementation during training in cardiac rehabilitation settings. On aerobic training indices and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

June 25, 2024

Last Update Submit

June 25, 2024

Conditions

Heart Failure With Reduced Ejection FractionHeart Failure With Mid Range Ejection Fraction

Outcome Measures

Primary Outcomes (5)

  • maximall aerobic training indices

    Maximum aerobic power will be tested before the start of the training program and immediately thereafter by a maximum rated stress test according to Proctol Bruce

    the test will be tested before the start of the training program and immediately thereafter

  • submaximal aerobic training indices

    Sub-maximal aerobic exertion: The assessment will include walking to fatigue on a sloping track and speed according to the Bruce Proctol phase where the patient was at 80% of the maximum heart rate in a pre-workout rated stress test.

    the test will be tested before the start of the training program and immediately thereafter

  • aerobic training indices

    six minute walk test

    the test will be tested before the start of the training program and immediately thereafter

  • Quality of life and disease severity

    Quality of life will be measured using The Kansas City Cardiomyopathy Questionnaire

    the test will be tested before the start of the training program and immediately thereafter

  • disease severity

    New York Heart Association-NYHA - A measure of the severity of the disease that includes 4 different levels: Level 1, which represents a condition in which there is impaired heart function but the patient is short of breath when performing level 4 exercise, when the patient is unable to exercise without shortness of breath. Even at rest

    the test will be tested before the start of the training program and immediately thereafter

Secondary Outcomes (1)

  • Examination of the involvement of the anaerobic system by measuring the concentration of lactic acid (HH) in a single submaximal effort with and without the addition of oxygen.

    the test will be tested before the start of the training program

Study Arms (2)

The experimental group will train with oxygen goggles in the aerobic part of the training

EXPERIMENTAL

pon admission of the patients to the Cardiac Rehabilitation Center in Laniado, a cardiologist's evaluation was performed to check inclusion and exclusion criteria for the study. As usual, the participants were asked to come with the results of the echocardiogram in the effort they made as part of the health services in the community. At this point, the doctor or physiotherapist asked those who met the inclusion criteria to participate in the study. After a detailed explanation of the study and what was required in it, those interested in participating were asked to give their written consent and were randomly divided into one of two groups (with oxygen "O2" and a control group). The two groups We trained with oxygen goggles in all aerobic efforts throughout the training program, the O2 group trained with an oxygen supplement of 5 liters/minute and the control group trained without oxygen enrichment with room air flow (placebo).

Other: train with oxygen and without oxygen enrichment (placebo).

The control group will train with oxygen goggles without oxygen enrichment (placebo).

PLACEBO COMPARATOR

pon admission of the patients to the Cardiac Rehabilitation Center in Laniado, a cardiologist's evaluation was performed to check inclusion and exclusion criteria for the study. As usual, the participants were asked to come with the results of the echocardiogram in the effort they made as part of the health services in the community. At this point, the doctor or physiotherapist asked those who met the inclusion criteria to participate in the study. After a detailed explanation of the study and what was required in it, those interested in participating were asked to give their written consent and were randomly divided into one of two groups (with oxygen "O2" and a control group). The two groups We trained with oxygen goggles in all aerobic efforts throughout the training program, the O2 group trained with an oxygen supplement of 5 liters/minute and the control group trained without oxygen enrichment with room air flow (placebo).

Other: train with oxygen and without oxygen enrichment (placebo).

Interventions

train with oxygen and without oxygen enrichment (placebo).OTHER

The experimental group will train with oxygen goggles in the aerobic part of the training The control group will train with oxygen goggles without oxygen enrichment (placebo).

The control group will train with oxygen goggles without oxygen enrichment (placebo).The experimental group will train with oxygen goggles in the aerobic part of the training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with heart failure with EF (ejection fraction) \<50% - according to echocardiography in an effort performed in the community.
  • Women and men in the 18-90 age range.

You may not qualify if:

  • Patients who are prevented from engaging in physical activity for any reason.
  • patients who are unable to walk due to orthopedic or neurological limitations.
  • patients with a disturbance in the electrical conduction at rest or exertion, which prevents them from exerting themselves.
  • patients with a decrease in Oxygen saturation below 95%..
  • children, who have no judgment, helpless patients and pregnant women will also not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laniado Hospital

Netanya, Israel

Location

Related Publications (15)

  • Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

    PMID: 23747642BACKGROUND

  • 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.

    PMID: 24622007BACKGROUND

  • Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, Tavazzi L, Smiseth OA, Gavazzi A, Haverich A, Hoes A, Jaarsma T, Korewicki J, Levy S, Linde C, Lopez-Sendon JL, Nieminen MS, Pierard L, Remme WJ; Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Jun;26(11):1115-40. doi: 10.1093/eurheartj/ehi204. Epub 2005 May 18. No abstract available.

    PMID: 15901669BACKGROUND

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

    PMID: 27207191BACKGROUND

  • McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. No abstract available.

    PMID: 22828712BACKGROUND

  • Blumenthal JA, Babyak MA, O'Connor C, Keteyian S, Landzberg J, Howlett J, Kraus W, Gottlieb S, Blackburn G, Swank A, Whellan DJ. Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA. 2012 Aug 1;308(5):465-74. doi: 10.1001/jama.2012.8720.

    PMID: 22851113BACKGROUND

  • Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, Whellan D, O'Connor C, Keteyian SJ, Coats A, Davos CH, Dalal HM, Dracup K, Evangelista LS, Jolly K, Myers J, Nilsson BB, Passino C, Witham MD, Yeh GY; ExTraMATCH II Collaboration. Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis. J Am Coll Cardiol. 2019 Apr 2;73(12):1430-1443. doi: 10.1016/j.jacc.2018.12.072.

    PMID: 30922474BACKGROUND

  • Jain SS, Cohen DJ, Zhang Z, Uriel N, Sayer G, Lindenfeld J, Abraham WT, Mack MJ, Stone GW, Arnold SV. Defining a Clinically Important Change in 6-Minute Walk Distance in Patients With Heart Failure and Mitral Valve Disease. Circ Heart Fail. 2021 Mar;14(3):e007564. doi: 10.1161/CIRCHEARTFAILURE.120.007564. Epub 2021 Mar 5. No abstract available.

    PMID: 33663234BACKGROUND

  • van der Meer S, Zwerink M, van Brussel M, van der Valk P, Wajon E, van der Palen J. Effect of outpatient exercise training programmes in patients with chronic heart failure: a systematic review. Eur J Prev Cardiol. 2012 Aug;19(4):795-803. doi: 10.1177/1741826711410516.

    PMID: 22988592BACKGROUND

  • Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.

    PMID: 32860412BACKGROUND

  • Beckers PJ, Possemiers NM, Van Craenenbroeck EM, Van Berendoncks AM, Wuyts K, Vrints CJ, Conraads VM. Comparison of three methods to identify the anaerobic threshold during maximal exercise testing in patients with chronic heart failure. Am J Phys Med Rehabil. 2012 Feb;91(2):148-55. doi: 10.1097/PHM.0b013e3182411d69.

    PMID: 22248807BACKGROUND

  • Achttien RJ, Staal JB, van der Voort S, Kemps HM, Koers H, Jongert MW, Hendriks EJ; Practice Recommendations Development Group. Exercise-based cardiac rehabilitation in patients with chronic heart failure: a Dutch practice guideline. Neth Heart J. 2015 Jan;23(1):6-17. doi: 10.1007/s12471-014-0612-2.

    PMID: 25492106BACKGROUND

  • Moore DP, Weston AR, Hughes JM, Oakley CM, Cleland JG. Effects of increased inspired oxygen concentrations on exercise performance in chronic heart failure. Lancet. 1992 Apr 4;339(8797):850-3. doi: 10.1016/0140-6736(92)90288-e.

    PMID: 1347866BACKGROUND

  • Shah P, Pellicori P, Rimmer S, Rigby AS, Clark AL. Effect of increased inspired oxygen on exercise performance in patients with heart failure and normal ejection fraction. Int J Cardiol. 2018 Oct 1;268:166-169. doi: 10.1016/j.ijcard.2018.05.029. Epub 2018 May 24.

    PMID: 29803343BACKGROUND

  • Restrick LJ, Davies SW, Noone L, Wedzicha JA. Ambulatory oxygen in chronic heart failure. Lancet. 1992 Nov 14;340(8829):1192-3. doi: 10.1016/0140-6736(92)92893-k.

    PMID: 1359262BACKGROUND

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Vladimir Vexler, Dr.

    Laniado Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The experimental group will train with oxygen goggles in the aerobic part of the training The control group will train with oxygen goggles without oxygen enrichment (placebo).
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be recruited for the study from all patients who apply to the Laniado Cardiac Rehabilitation Center. A cardiologist evaluation will be performed to examine the inclusion and research cartridges, as is customary at the venue participants will be asked to come up with echocardiogram results in an effort they have made in the community. At this point, participants who meet the criteria will be asked to be included in the study to participate in the study. After a detailed explanation they will be asked to give their written consent and will be randomly divided into groups. The experimental group will train with oxygen goggles in the aerobic part of the training The control group will train with oxygen goggles without oxygen enrichment (placebo).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

February 10, 2022

Primary Completion

August 20, 2023

Study Completion

August 20, 2023

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting from the publication of the research for 15 years
Access Criteria
An application should be submitted to the research unit manager of Laniado Hospital

Locations

IL(1)