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Resistance Training in Cardiovascular Disease Patients (RT in CVD)

Primary Purpose

Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Aerobic interval training combined with high intensity resistance training
Aerobic interval training combined with low intensity resistance training
Aerobic interval training
Sponsored by
General Hospital Murska Sobota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring resistance training, coronary artery disease, heart failure, hemodynamic response, cardiac rehabilitation, aerobic training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Stable patients with documented CAD with clinical event (>1 month after acute coronary syndrome and/or percutaneous coronary intervention) or coronarography and/or
  • Stable Heart Failure patients with documented reduced ejection fraction (>40-45 %)
  • age >18 years
  • NYHA class I-III
  • Cardiopulmonary exercise test without ECG abnormalities

Exclusion Criteria:

  • Unstable CHD
  • Decompensated HF
  • Uncontrolled arrhythmias
  • Severe and symptomatic aortic stenosis
  • Acute myocarditis, endocarditis, or pericarditis
  • Aortic dissection
  • Marfan syndrome
  • Musculoskeletal limitations

Sites / Locations

  • Division of Cardiology, General Hospital Murska SobotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Aerobic interval training with high loads resistance training

Aerobic interval training with low loads resistance training

Aerobic interval training

Arm Description

Patient to be randomised into "combined aerobic training with high loads resistance training group".

Patient to be randomised into "combined aerobic training with low loads resistance training group".

Patient to be randomised into "aerobic training training group".

Outcomes

Primary Outcome Measures

Change in Maximal aerobic capacity
Measured as change in VO2 max (ml/kg/min)
Change in Maximal voluntary contraction of knee extensors
Measured as change in maximal isometric torque of knee extensors

Secondary Outcome Measures

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured as change in HOMA IR (%)
Change in glucose levels
Measured as change in glucose levels (mmol/L)
Change in insulin levels
Measured as change in insulin levels
Change in systolic blood pressure during high and low load resistance exercise
Measured as change in systolic blood pressure during resistance exercise compared to baseline (pre-exercise) values
Change in diastolic blood pressure during high and low load resistance exercise
Measured as change in diastolic blood pressure during resistance exercise compared to baseline (pre-exercise)
Change in heart rate during high and low load resistance exercise
Measured as change in heart rate during resistance exercise compared to baseline (pre-exercise)
Change in rating of perceived exertion during high and low load resistance exercise
Measured as change of rating of perceived exertion (0-10) during resistance exercise compared to baseline (pre-exercise)
Change in Short Physical Performance Battery (SPPB) total score
Measured as change in points of the SPPB after 12 weeks compared to baseline
Change in time of the "Up and Go" test
Measured as change of time (s) in "Up and Go" test
Change in Grip strength test (kg)
Measured as change of kg in Grip strength test
Change in Arm curl test (number of repetitions)
Measured as change of number of repetitions in Arm curl test
Change in time of the Sit to stand test
Measured as change in time (s) of the Sit and stand test
Change in One Leg Heel Raise test (number of repetitions)
Measured as change of number of repetitions in One leg heel raise test
Change in total energy expenditure
Measured as change in kcal using accelerometry data
Change in sedentary activity level
Measured as change in minutes spent in sedentary activity level using accelerometry data
Change in moderate to vigorous physical activity level
Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data
Change in the Back Scratch test
Measured as change in cm of the Back Scratch test
Change in the Chair Sit and Reach test
Measured as change in cm of the Chair Sit and Reach test
Change in Stork balance test
Measured as change in seconds of the Stork balance test
Change in Short form Health related quality of life questionnaire (SF-12)
Measured as change in score of the SF-12
Change in Patients health questionnaire score (PHQ-9)
Measured as change in points of PHQ-9 questionnaire
Change in Respiratory Exchange Ratio (RER)
Measured as percent change of RER during cardiopulmonary exercise test
Change in Ve/VCO2 slope ratio
Measured as change in VE/VCO2 slope
Change in Tumor necrosis factor alpha (TNF-alpha) level
Measured as change in TNF-alpha
Change in Interleukin 6 (IL-6) level
Measured as change in IL-6 level
Change in Human Growth hormone (hGH) level
Measured as change in hGH level
Change in Insulin like Growth Factor 1 (IGF-1)
Measured as change in IGF-1 level
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Measured as change in NT-proBNP level

Full Information

First Posted
October 29, 2020
Last Updated
November 18, 2020
Sponsor
General Hospital Murska Sobota
Collaborators
University of Ljubljana, University of Primorska
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1. Study Identification

Unique Protocol Identification Number
NCT04638764
Brief Title
Resistance Training in Cardiovascular Disease Patients
Acronym
RT in CVD
Official Title
Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 23, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
November 26, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital Murska Sobota
Collaborators
University of Ljubljana, University of Primorska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study coronary artery disease patients and patients with heart failure will be randomly assigned to three training groups: combined aerobic interval training with high intensity resistance training, combined aerobic interval training with low intensity resistance training and aerobic interval training.
Detailed Description
Exercise-based cardiac rehabilitation programmes have predominantly used aerobic-dynamic exercise modalities, whereas resistance training have been discouraged in patients with cardiovascular disease, due to safety concerns related to cardiovascular response (heart rate and blood pressure) during the exertion. Contrary to such concerns, recent hemodynamic studies have reported lower blood pressure and heart rate during higher intensity resistance training (>70 % 1-RM) compared to lower intensity resistance training (>40 % 1-RM). Furthermore, the latest meta analysis have demonstrated that combined resistance training with standard aerobic interval training has been superior than aerobic training alone in several aspects of health. However, there is still huge heterogeneity in training intervention design, also there still lacks studies to further elucidate the effects of high intensity resistance training combined with aerobic training on physical performance (aerobic capacity, muscle strength, balance), body composition, quality of life, morbidity, mortality, etc. Therefore, the aim of this study was to examine the effects of high (70%-80 % 1-RM) versus low loads (30%- 40 % 1-RM) resistance training in combination with aerobic interval cycling (50 % -80% of baseline peak Power output) in coronary artery disease patients and patients with heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Keywords
resistance training, coronary artery disease, heart failure, hemodynamic response, cardiac rehabilitation, aerobic training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomisation with three parallel intervention groups
Masking
None (Open Label)
Masking Description
Baseline and post-training measurement will be performed by experienced research nurse and physiotherapist, which will not participate in intervention.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic interval training with high loads resistance training
Arm Type
Active Comparator
Arm Description
Patient to be randomised into "combined aerobic training with high loads resistance training group".
Arm Title
Aerobic interval training with low loads resistance training
Arm Type
Active Comparator
Arm Description
Patient to be randomised into "combined aerobic training with low loads resistance training group".
Arm Title
Aerobic interval training
Arm Type
Active Comparator
Arm Description
Patient to be randomised into "aerobic training training group".
Intervention Type
Other
Intervention Name(s)
Aerobic interval training combined with high intensity resistance training
Other Intervention Name(s)
Aerobic and high intensity strength training
Intervention Description
Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 70 %- 80 % of one repetition maximum (1-RM)).
Intervention Type
Other
Intervention Name(s)
Aerobic interval training combined with low intensity resistance training
Other Intervention Name(s)
Aerobic and low intensity strength training
Intervention Description
Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 30 %- 40 % 1-RM).
Intervention Type
Other
Intervention Name(s)
Aerobic interval training
Other Intervention Name(s)
Aerobic training
Intervention Description
Patients enrolled in arm of the study will perform 12 weeks of aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing).
Primary Outcome Measure Information:
Title
Change in Maximal aerobic capacity
Description
Measured as change in VO2 max (ml/kg/min)
Time Frame
Change in maximal aerobic capacity at 12 weeks compared to baseline
Title
Change in Maximal voluntary contraction of knee extensors
Description
Measured as change in maximal isometric torque of knee extensors
Time Frame
Change in maximal isometric torque at 12 weeks compared to baseline
Secondary Outcome Measure Information:
Title
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Description
Measured as change in HOMA IR (%)
Time Frame
Change in HOMA-IR at 12 weeks compared to baseline
Title
Change in glucose levels
Description
Measured as change in glucose levels (mmol/L)
Time Frame
Change in glucose levels at 12 weeks compared to baseline
Title
Change in insulin levels
Description
Measured as change in insulin levels
Time Frame
Change in insulin levels at 12 weeks compared to baseline
Title
Change in systolic blood pressure during high and low load resistance exercise
Description
Measured as change in systolic blood pressure during resistance exercise compared to baseline (pre-exercise) values
Time Frame
Change of systolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Title
Change in diastolic blood pressure during high and low load resistance exercise
Description
Measured as change in diastolic blood pressure during resistance exercise compared to baseline (pre-exercise)
Time Frame
Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Title
Change in heart rate during high and low load resistance exercise
Description
Measured as change in heart rate during resistance exercise compared to baseline (pre-exercise)
Time Frame
Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Title
Change in rating of perceived exertion during high and low load resistance exercise
Description
Measured as change of rating of perceived exertion (0-10) during resistance exercise compared to baseline (pre-exercise)
Time Frame
Change of rating of perceived exertion (score 0-10, 0-no exertion, 10-maximal exertion) during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Title
Change in Short Physical Performance Battery (SPPB) total score
Description
Measured as change in points of the SPPB after 12 weeks compared to baseline
Time Frame
Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline
Title
Change in time of the "Up and Go" test
Description
Measured as change of time (s) in "Up and Go" test
Time Frame
Change in seconds of the "Up and Go" test after 12 weeks compared to baseline
Title
Change in Grip strength test (kg)
Description
Measured as change of kg in Grip strength test
Time Frame
Change in kg of Grip strength test after 12 weeks compared to baseline
Title
Change in Arm curl test (number of repetitions)
Description
Measured as change of number of repetitions in Arm curl test
Time Frame
Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline
Title
Change in time of the Sit to stand test
Description
Measured as change in time (s) of the Sit and stand test
Time Frame
Change in seconds of the Sit to stand test after 12 weeks compared to baseline
Title
Change in One Leg Heel Raise test (number of repetitions)
Description
Measured as change of number of repetitions in One leg heel raise test
Time Frame
Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline
Title
Change in total energy expenditure
Description
Measured as change in kcal using accelerometry data
Time Frame
Change in kcal after 12 weeks compared to baseline
Title
Change in sedentary activity level
Description
Measured as change in minutes spent in sedentary activity level using accelerometry data
Time Frame
Change in minutes of sedentary activity after 12 weeks compared to baseline
Title
Change in moderate to vigorous physical activity level
Description
Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data
Time Frame
Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline
Title
Change in the Back Scratch test
Description
Measured as change in cm of the Back Scratch test
Time Frame
Change in cm of the Back Scratch test after 12 weeks compared to baseline
Title
Change in the Chair Sit and Reach test
Description
Measured as change in cm of the Chair Sit and Reach test
Time Frame
Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline
Title
Change in Stork balance test
Description
Measured as change in seconds of the Stork balance test
Time Frame
Change in seconds of the Stork balance test after 12 weeks compared to baseline
Title
Change in Short form Health related quality of life questionnaire (SF-12)
Description
Measured as change in score of the SF-12
Time Frame
Change in score of the Short form 12 items health related questionnaire (12 points -the lowest score, 47 points the highest score) after 12 weeks compared to baseline
Title
Change in Patients health questionnaire score (PHQ-9)
Description
Measured as change in points of PHQ-9 questionnaire
Time Frame
Change in score of the Patients health 9-item questionnaire (0 points-the best outcome, 27 points-the worse outcome) after 12 weeks compared to baseline
Title
Change in Respiratory Exchange Ratio (RER)
Description
Measured as percent change of RER during cardiopulmonary exercise test
Time Frame
Change in % after 12 weeks compared to baseline
Title
Change in Ve/VCO2 slope ratio
Description
Measured as change in VE/VCO2 slope
Time Frame
Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline
Title
Change in Tumor necrosis factor alpha (TNF-alpha) level
Description
Measured as change in TNF-alpha
Time Frame
Change in TNF-alpha level after 12 weeks compared to baseline
Title
Change in Interleukin 6 (IL-6) level
Description
Measured as change in IL-6 level
Time Frame
Change in IL-6 level after 12 weeks compared to baseline
Title
Change in Human Growth hormone (hGH) level
Description
Measured as change in hGH level
Time Frame
Change in hGH level after 12 weeks compared to baseline
Title
Change in Insulin like Growth Factor 1 (IGF-1)
Description
Measured as change in IGF-1 level
Time Frame
Change in IGF-1 level after 12 weeks compared to baseline
Title
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Description
Measured as change in NT-proBNP level
Time Frame
Change in NT-proBNP level after 12 weeks compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Stable patients with documented CAD with clinical event (>1 month after acute coronary syndrome and/or percutaneous coronary intervention) or coronarography and/or Stable Heart Failure patients with documented reduced ejection fraction (>40-45 %) age >18 years NYHA class I-III Cardiopulmonary exercise test without ECG abnormalities Exclusion Criteria: Unstable CHD Decompensated HF Uncontrolled arrhythmias Severe and symptomatic aortic stenosis Acute myocarditis, endocarditis, or pericarditis Aortic dissection Marfan syndrome Musculoskeletal limitations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitja Lainščak, MD, PhD
Phone
+386 (0)2 5123733
Email
mitja.lainscak@guest.arnes.si
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Kambič, MKin
Email
tim.kambic@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitja Lainščak, MD, PhD
Organizational Affiliation
General Hospital Murska Sobota; University of Ljubljana, Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Kambič, MKin
Organizational Affiliation
General Hospital Murska Sobota; University of Ljubljana, Faculty of Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, General Hospital Murska Sobota
City
Murska Sobota
ZIP/Postal Code
9000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitja Lainščak, MD, PhD
Email
mitja.lainscak@guest.arnes.si
First Name & Middle Initial & Last Name & Degree
Tim Kambič, MKin
Email
tim.kambic@gmail.com
First Name & Middle Initial & Last Name & Degree
Tim Kambič, MKin
First Name & Middle Initial & Last Name & Degree
Mitja Lainščak, MD, PhD
First Name & Middle Initial & Last Name & Degree
Vedran Hadžić, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jerneja Farkaš Lainščak, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nejc Šarabon, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36367488
Citation
Kambic T, Sarabon N, Hadzic V, Lainscak M. Physical activity and sedentary behaviour following combined aerobic and resistance training in coronary artery disease patients: A randomised controlled trial. Int J Cardiol. 2023 Jan 1;370:75-79. doi: 10.1016/j.ijcard.2022.10.157. Epub 2022 Oct 29.
Results Reference
derived
PubMed Identifier
36093154
Citation
Kambic T, Sarabon N, Lainscak M, Hadzic V. Combined resistance training with aerobic training improves physical performance in patients with coronary artery disease: A secondary analysis of a randomized controlled clinical trial. Front Cardiovasc Med. 2022 Aug 24;9:909385. doi: 10.3389/fcvm.2022.909385. eCollection 2022.
Results Reference
derived
PubMed Identifier
34301669
Citation
Kambic T, Sarabon N, Hadzic V, Lainscak M. Effects of high-load and low-load resistance training in patients with coronary artery disease: rationale and design of a randomised controlled clinical trial. BMJ Open. 2021 Jul 22;11(7):e051325. doi: 10.1136/bmjopen-2021-051325.
Results Reference
derived
PubMed Identifier
33917770
Citation
Kambic T, Hadzic V, Lainscak M. Hemodynamic Response to High- and Low-Load Resistance Exercise in Patients with Coronary Artery Disease: A Randomized, Crossover Clinical Trial. Int J Environ Res Public Health. 2021 Apr 8;18(8):3905. doi: 10.3390/ijerph18083905.
Results Reference
derived

Learn more about this trial

Resistance Training in Cardiovascular Disease Patients

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