NCT02387411

Brief Summary

Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to reduced exercise tolerance, quality of life and mortality rates. Exercise training is a major component of rehabilitation / secondary prevention interventions, inducing significant beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity and quality of life, while a positive impact on hospitalization and mortality reduction should not be also excluded. There has been growing interest in the characteristics and modalities of exercise training able to induce optimal benefits. High intensity and interval mode have been shown to induce greater benefits than moderate intensity and continuous mode regimes. Additionally, there has been sound rationale for the inclusion of strength training, which has been also shown able to yield benefits in terms of exercise capacity and quality of life. However, there haven't been much data on the so called combined regimes, which include both aerobic exercise and strength training. This study aims at investigating the effects of combined high-intensity interval and strength training compared to high-intensity interval exercise alone in CHF.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2010

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

5.1 years

First QC Date

February 19, 2015

Last Update Submit

March 12, 2015

Conditions

Keywords

heart failureaerobic exercisestrength trainingcardiopulmonary rehabilitationhigh-intensity exercise training

Outcome Measures

Primary Outcomes (1)

  • aerobic exercise capacity (assessed by cardiopulmonary exercise testing)

    3 months

Secondary Outcomes (4)

  • strength exercise capacity (assessed by 1-repetition maximum test)

    3 months

  • quality of life (assessed by MLWHF questionnaire)

    3 months

  • quadriceps local adaptations (assessed by muscle biopsies)

    3 months

  • quadriceps cross sectional area (assessed by CT)

    3 months

Study Arms (2)

Interval group

ACTIVE COMPARATOR

high-intensity interval exercise training

Other: High-intensity interval exercise training

Combined group

ACTIVE COMPARATOR

combined exercise training

Other: Combined exercise training

Interventions

High-intensity interval exercise training \[4 reps \* (4 min at 80% VO2peak + 3 min at 50% VO2peak)\]

Interval group

High intensity \[2 reps \* (4 min at 80% VO2peak + 3 min at 50% VO2peak)\] and strength exercise training (2-4 sets, 10-12 reps, 60-65% 1RM, for quadriceps and hamstrings, 14 min in total)

Combined group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable heart failure
  • ejection fraction \<=45%
  • optimal medical treatment
  • NYHA class \<=III

You may not qualify if:

  • contraindications for maximal cardiopulmonary exercise testing (CPET)
  • moderate to severe COPD
  • inability to follow exercise programs due to orthopaedic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens

Athens, 10675, Greece

Location

Related Publications (3)

  • Tryfonos A, Tzanis G, Karatzanos Epsilon, Koutsilieris M, Nanas S, Philippou A. Inflammation- and Tissue Remodeling-Related Gene Responses in Skeletal Muscle of Heart Failure Patients Following High-Intensity Interval Training. Rev Cardiovasc Med. 2023 Feb 6;24(2):46. doi: 10.31083/j.rcm2402046. eCollection 2023 Feb.

  • Alshamari M, Kourek C, Sanoudou D, Delis D, Dimopoulos S, Rovina N, Nanas S, Karatzanos E, Philippou A. Does the Addition of Strength Training to a High-Intensity Interval Training Program Benefit More the Patients with Chronic Heart Failure. Rev Cardiovasc Med. 2023 Jan 16;24(1):29. doi: 10.31083/j.rcm2401029. eCollection 2023 Jan.

  • Tryfonos A, Tzanis G, Pitsolis T, Karatzanos E, Koutsilieris M, Nanas S, Philippou A. Exercise Training Enhances Angiogenesis-Related Gene Responses in Skeletal Muscle of Patients with Chronic Heart Failure. Cells. 2021 Jul 28;10(8):1915. doi: 10.3390/cells10081915.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Serafim Nanas, MD, Prof.

    Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Critical Care Medicine

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 13, 2015

Study Start

May 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations