Overview

This trial is active, not recruiting.

Conditions coronary artery disease, cardiac rehabilitation exercise
Treatments 90 minutes traditional cardiac rehabilitation, 90 minutes combined endurance and resistance exercise once a week plus 90 minutes traditional cardiac rehabilitation once a week over six months
Sponsor Technische Universität München
Start date February 2011
End date December 2013
Trial size 70 participants
Trial identifier NCT01921036, 2931/10, DRKS00003625

Summary

Seventy patients in cardiac rehabilitation with maximal exercise capacity less than 1.4 watt per kilogram bodyweight will be randomized 1:1 into either an intervention training (IN) group or usual care (UC). The IN patients will perform supervised endurance and resistance exercise for approximately 90 minutes once a week and traditional cardiac rehabilitation (TCR) once a week; the UC patients will perform TCR twice a week. The intervention is planned for six months with a follow-up of a further six months. The primary investigation is differences between IN and UC with regard to changes in exercise capacity (max watt/kgBW).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Experimental)
90 minutes combined endurance and resistance exercise once a week plus 90 minutes traditional cardiac rehabilitation once a week over six months
90 minutes combined endurance and resistance exercise once a week plus 90 minutes traditional cardiac rehabilitation once a week over six months
Moderate endurance and resistance exercise once a week over six months
(Active Comparator)
90 minutes of traditional cardiac rehabilitation twice a week over six months
90 minutes traditional cardiac rehabilitation
mutifactoral cardiac rehabilitation

Primary Outcomes

Measure
Change from baseline in maximal exercise capacity (watt/kgBW)
time frame: six months

Secondary Outcomes

Measure
Change from baseline in maximal exercise capacity (watt/kgBW)
time frame: 12 months
Change from baseline in anthropometric measures
time frame: six and 12 months
Change from baseline in Health Relates Quality of Life (HRQoL as measured by questionnaires)
time frame: six and 12 months
Number of patients with adverse events (AE; documented)
time frame: six and 12 months
Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications))
time frame: six and 12 months
Change in physical activity level (based on 7-day accelerometry)
time frame: six and 12 months
Change from baseline in upper and lower body muscular strength (1RM; kg)
time frame: six and 12 months
Change from baseline in anthropometric measures
time frame: six and 12 months
Change from baseline in blood pressure (Systolic and Dystolic;mmHg)
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - participation in cardiac rehabilitation - written consent - < 1.4 watt/kgBW exercise capacity not more than 12 weeks before study begin Exclusion Criteria: - >= 1.4 watt/kgBW - contraindications to exercise participation - hospitalized for CVD within six weeks of inclusion - acute illness/injury (e.g. fever) - chronic drug abuse - inability to understand study instructions - unwillingness to participate

Additional Information

Official title Individuell Dosiertes Kraft-ausdauer-training in Ambulanten Herzgruppen - Einfluss Auf Koerperliche Belastbarkeit Von Herzpatienten.
Principal investigator Jeffrey W Christle, M.A.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Technische Universität München.