Aerobic Interval vs Continuous Training on Heart Rate-Power Decoupling in Ischemic Heart Disease

NCT07485400 | Not Yet Recruiting

• 2 other identifiers: Interval training cardioTFM-UCM-RC-2026
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, parallel-group clinical trial with assessor and statistical analyst blinding, conducted at a single center. Participants with stable ischemic heart disease enrolled in a cardiac rehabilitation program will be randomly allocated to one of two aerobic exercise interventions: long extensive continuous aerobic training (zone 2) or long extensive aerobic interval training (zone 3). Both groups will participate in supervised exercise sessions twice weekly for a period of 8 weeks, integrated into the standard cardiac rehabilitation program. Assessments will be performed at baseline, immediately after the intervention period (8 weeks), and after a 4-week follow-up period without supervised training to evaluate potential detraining effects. The primary outcome is heart rate-power decoupling during a prolonged submaximal cycling exercise test, used as an indicator of cardiovascular efficiency. Secondary outcomes include heart rate response during submaximal exercise, exercise tolerance, heart rate recovery, blood pressure, functional capacity, quality of life, and adherence to the training program. The objective of this study is to compare the effects of long extensive aerobic interval training versus long extensive continuous training on heart rate-power decoupling and related cardiovascular and functional outcomes in patients with ischemic heart disease undergoing cardiac rehabilitation.

Conditions

Stable Coronary Artery Disease (CAD), Myocardial Infarction

Keywords

Cardiac rehabilitation; High-Intensity Interval Training; Coronary Artery Disease; Exercise Therapy; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Change in heart rate-power slope during a submaximal incremental cycling test

  The heart rate-power slope will be assessed during a submaximal incremental cycling test performed on a cycle ergometer. The protocol will start at 20 W, with workload increases of 10 W every 2 minutes until submaximal termination criteria are reached. Heart rate will be continuously monitored using a validated chest strap device. The heart rate-power slope will be calculated as: (Heart rate\_initial - Heart rate\_final) / (Power\_initial - Power\_final) The result will be expressed in beats per minute per watt (bpm/W). Higher values indicate reduced cardiovascular efficiency.

  Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 12)

Study Arms (2)

Control Group: Extensive Continuous Training

ACTIVE COMPARATOR

Participants assigned to this arm will undergo an 8-week continuous aerobic training program on a cycle ergometer, with two supervised 90-minute sessions per week. Each session includes: Warm-up (10-15 minutes) consisting of low-intensity pedaling (≤60% max HR) and joint mobility exercises. Main training block: 40 minutes of continuous cycling at moderate intensity (65-75% max HR), individually adjusted based on baseline assessment. Cool-down (5-10 minutes) with light pedaling and gentle stretching. Additionally, all participants will complete a standardized strength-resistance and mobility training program supervised by specialized physiotherapists, identical for both groups, including controlled exercises with bodyweight and light resistance.

Other: Control Group (A):

Long Extensive Interval Training

EXPERIMENTAL

Participants assigned to this arm will complete an 8-week aerobic interval training program on a cycle ergometer, with two supervised 90-minute sessions weekly. Each session includes: Warm-up (10-15 minutes) of low-intensity pedaling (≤60% max HR) and joint mobility exercises. Main training block: 8 intervals of 3 minutes at high subthreshold intensity (75-85% max HR), alternating with 2 minutes of active recovery at low-to-moderate intensity (65-70% max HR), totaling approximately 40 minutes. Cool-down (5-10 minutes) with light pedaling and stretching. As in the other group, all participants will engage in a standardized strength-resistance and mobility program identical across groups.

Other: Intervention Group

Interventions

Intervention Group OTHER

Participants will undergo an 8-week aerobic interval training program on a cycle ergometer, consisting of two weekly supervised sessions of 90 minutes. Each session includes: Warm-up: 10-15 minutes of low-intensity continuous pedaling (≤60% max HR) and joint mobility exercises. Main aerobic interval training: 8 intervals of 3 minutes pedaling at 75-85% of maximum heart rate, each followed by 2 minutes of active recovery at 65-70% max HR. Total aerobic training duration approximately 40 minutes. Cool-down: 5-10 minutes of light pedaling and stretching. Heart rate, blood pressure, and oxygen saturation will be continuously monitored. Safety criteria for session interruption will be applied.

Long Extensive Interval Training

Control Group (A): OTHER

Participants will complete an 8-week continuous aerobic training program on a cycle ergometer, with two weekly supervised 90-minute sessions, including: Warm-up: 10-15 minutes of low-intensity continuous pedaling (≤60% max HR) and joint mobility exercises. Main aerobic continuous training: 40 minutes of continuous pedaling at 65-75% of maximum heart rate. Cool-down: 5-10 minutes of light pedaling and stretching. Monitoring and safety procedures as in the intervention group.

Control Group: Extensive Continuous Training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of cardiovascular disease requiring cardiac rehabilitation, with medical indication for a supervised exercise training program.
• Prognostic risk classified as low or moderate according to the clinical risk stratification established in the unit, considering:
• Killip class I or II (absence or mild heart failure)¹.
• Absence of recent acute myocardial infarction (\< 1 month) or presence of a stable previous infarction.
• Stable and well-controlled cardiovascular symptoms.
• Physical capacity demonstrated in functional tests ≥ 5 METs, preferably \> 7 METs for low-risk patients.
• Age between 40 and 75 years.
• Ability to perform physical exercise without absolute contraindications.
• Written informed consent and willingness to attend the scheduled sessions twice per week for 8 weeks.

You may not qualify if:

• High prognostic risk, defined by:
• Killip class \> III (moderate to severe heart failure).
• Recent acute myocardial infarction (\< 1 month) with clinical instability.
• Active anginal symptoms or decompensated heart failure.
• Physical capacity \< 5 METs on functional testing, indicating severely reduced exercise capacity.
• Presence of complex or unstable arrhythmias contraindicating vigorous physical exercise.
• Concomitant diseases that may limit participation or compromise safety (e.g., advanced pulmonary disease, severe renal failure, severe neuromuscular disorders).
• Absolute medical contraindications to maximal strength or interval training (e.g., aortic aneurysm, uncontrolled hypertension).
• Participation in another clinical trial or concurrent rehabilitation program.
• Inability to comply with attendance requirements or to follow the intervention protocol.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Related Publications (5)

• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

  PMID: 26764059 BACKGROUND

• Ellingsen O, Halle M, Conraads V, Stoylen A, Dalen H, Delagardelle C, Larsen AI, Hole T, Mezzani A, Van Craenenbroeck EM, Videm V, Beckers P, Christle JW, Winzer E, Mangner N, Woitek F, Hollriegel R, Pressler A, Monk-Hansen T, Snoer M, Feiereisen P, Valborgland T, Kjekshus J, Hambrecht R, Gielen S, Karlsen T, Prescott E, Linke A; SMARTEX Heart Failure Study (Study of Myocardial Recovery After Exercise Training in Heart Failure) Group. High-Intensity Interval Training in Patients With Heart Failure With Reduced Ejection Fraction. Circulation. 2017 Feb 28;135(9):839-849. doi: 10.1161/CIRCULATIONAHA.116.022924. Epub 2017 Jan 12.

  PMID: 28082387 BACKGROUND

• Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.

  PMID: 17548726 BACKGROUND

• Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000.

  PMID: 22694349 BACKGROUND

• Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.

  PMID: 15121495 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gustavo Plaza-Manzano, PhD

  Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Isidro Fernández-López, PhD

CONTACT

+34625598970; isidrofe@ucm.es

Alberto Martos-Monedero, PT

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to blinding the outcome assessor and the statistical analyst, no masking will be applied to other parties involved in the study. Due to the practical nature of the intervention, the personnel responsible for administering the training (physiotherapists) and the participants themselves will be aware of group allocation. Blinding of the intervention providers or the participants is not planned. Thus, the only blinding implemented will be that of the assessor and the analyst, ensuring objectivity in outcome measurement and data analysis, and minimizing potential bias in these processes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD.

Model Details: This is an 8-week randomized, parallel-group clinical trial with 1:1 allocation to intervention and control groups. Participants will undergo two 90-minute training sessions per week. Pre- and post-intervention assessments will be conducted, with a follow-up 4 weeks after intervention completion to evaluate detraining effects.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: March 17, 2026
• Primary Completion: May 17, 2026
• Study Completion (Estimated): July 3, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03