The Effects of Combined Exercise Training on Exercise Capacity in Cardiac Rehabilitation

NCT01921036 | Completed DMC

• 2 other identifiers: 2931/10DRKS00003625
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in maximal exercise capacity (watt/kgBW)

  six months

Secondary Outcomes (9)

• Change from baseline in maximal exercise capacity (watt/kgBW)

  12 months

• Change from baseline in anthropometric measures

  six and 12 months

• Change from baseline in Health Relates Quality of Life (HRQoL as measured by questionnaires)

  six and 12 months

• Number of patients with adverse events (AE; documented)

  six and 12 months

• Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications))

  six and 12 months

Study Arms (2)

combined exercise

EXPERIMENTAL

90 minutes combined endurance and resistance exercise once a week plus 90 minutes traditional cardiac rehabilitation once a week over six months

Procedure: combined exercise

traditional cardiac rehabilitation

ACTIVE COMPARATOR

The group-based program is offered for 90 minutes twice a week and is a combination of gymnastics, coordination and flexibility exercises, and includes educational components targeting diet and nutrition, stress and relaxation, methods for coping with CVD and behavioral and lifestyle change.

Procedure: traditional cardiac rehabilitation

Interventions

traditional cardiac rehabilitation PROCEDURE

mutifactoral cardiac rehabilitation

traditional cardiac rehabilitation

combined exercise PROCEDURE

Moderate endurance and resistance exercise once a week over six months

combined exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• participation in cardiac rehabilitation
• written consent
• \< 1.4 watt/kgBW exercise capacity not more than 12 weeks before study begin

You may not qualify if:

• \>= 1.4 watt/kgBW
• contraindications to exercise participation
• acute illness/injury (e.g. fever)
• chronic drug abuse
• inability to understand study instructions
• unwillingness to participate

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar/ Technische Universitaet Muenchen

Munich, 80992, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jeffrey W Christle, M.A.

  Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: August 13, 2013
• Study Start: February 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

DE (1)