Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes

NCT03208751 | Unknown

• 1 other identifier: 5132/11
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.

Conditions

Exercise Training; Coronary Artery Disease; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in VO2peak in ml/kg/min

  Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention

  6 months

Secondary Outcomes (11)

• Change in HbA1c for patients with diabetes

  6 months

• Change in hsCRP

  6 months

• Change in E/e'

  6 months

• Change in quality of life measured by SF-36

  6 months

• Change in insulin IU

  6 months

Study Arms (1)

Exercise training

OTHER

All patients were included in the exercise training group

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

Exercise intervention was divided into 3 phases: Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14). Nutritional counseling is offered up to 4 times in 6 months on an individual basis.

Exercise training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery disease and/or diabetes mellitus
• Heart failure

You may not qualify if:

• all conditions which are not compatible with exercise training:
• severe orthopedic disorders
• severe psychiatric disease
• severe valve insufficiency
• presence of myocardial ischemia (decision made by cardiologist)

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar/ Technische Universitaet Muenchen

Munich, 81675, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martin Halle, Prof.

  Technical University Munic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A single-arm intervention with exercise training as secondary prevention strategy

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: July 6, 2017
• Study Start: April 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)