- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01921036
The Effects of Combined Exercise Training on Exercise Capacity in Cardiac Rehabilitation (DOPPELHERZ)
Individuell Dosiertes Kraft-ausdauer-training in Ambulanten Herzgruppen - Einfluss Auf Koerperliche Belastbarkeit Von Herzpatienten.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The DOPPELHERZ (The influence of individualized resistance-endurance exercise training on maximal power output in outpatient cardiac rehabilitation) randomized controlled trial was performed at the Department of Prevention and Sports Medicine, Klinikum rechts der Isar in Munich, Germany. 70 patients eligible for and/or participating in cardiac rehabilitation were randomized to six months in an individualized combined exercise group (ICE) or group- based cardiac rehabilitation (GCR), considered usual care in this patient population.
All patients gave written informed consent, the study protocol was approved by the local university hospital ethics committee, all procedures were conducted according to the Declaration of Helsinki.
Participants: All patients were American Heart Association Class "C" (moderate to high risk) based on the presence of cardiac disease and maximal power output of <5 METs (corresponding to <1.4 W/kg body weight), who met eligibility criteria for CR at the time of recruitment. Patients with decompensated or highly symptomatic (NYHA IV) heart failure, acute illness or injury, cardiac hospitalizations within six weeks of inclusion, drug abuse, unstable blood pressure or arrhythmias, high grade valve stenosis or instable diabetes mellitus were excluded.
Primary endpoint: The primary endpoint was change in maximal relative power output (W/kg) measured by CPX after six months.
Exercise training program In both the intervention and usual care arms of the study, exercise training was prescribed twice weekly over a period of six months, and all exercise sessions were led by certified exercise instructors and monitored by physicians.
Group-based cardiac rehabilitation (GCR): The GCR group performed regular exercise in a state-sanctioned cardiac rehabilitation group. This form of GCR is considered Phase III aftercare and has been described elsewhere9. Briefly, GCR patients received moderate-intensity heart rate targets from exercise cardiologists based on CPX results. The group-based program is offered for 90 minutes twice a week and is a combination of gymnastics (including endurance and resistance components), 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. The GCR sessions were conducted at a local university gymnasium and were performed in groups of up to 15 participants, as recommended by the German Federal Association for Rehabilitation.
Individualized combined exercise (ICE): The ICE group participated in once-weekly individualized combined resistance-endurance exercise training for 60 minutes and once-weekly traditional group-based cardiac rehabilitation as described above. The ICE intervention included 30 minutes of endurance exercise at 60-70% VO2peak and RPE 11-14 and five resistance exercises (chest press, leg press, lat pull-downs, shoulder press and seated cable row) following the recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation (DGPR) and targeting the large muscle groups at an RPE<16. For the first three months, patients performed two sets of 12-25 repetitions at 30-50% 1RM; after three months patients were retested and thereafter performed two sets of 8-15 repetitions at 40-60% 1RM. The ICE sessions were located at the university sports medicine rehabilitation center and performed in groups of not more than four patients. They were instructed at a maximum 2:1 participant to therapist ratio.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Munich, Tyskland, 80992
- Klinikum rechts der Isar/ Technische Universitaet Muenchen
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: combined exercise
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
|
|
Aktiv komparator: traditional cardiac rehabilitation
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.
|
mutifactoral cardiac rehabilitation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in maximal exercise capacity (watt/kgBW)
Tidsramme: six months
|
six months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in maximal exercise capacity (watt/kgBW)
Tidsramme: 12 months
|
12 months
|
|
|
Change from baseline in anthropometric measures
Tidsramme: six and 12 months
|
Change from baseline in waist to hip circumference ratio, body mass index, percent body fat and weight.
|
six and 12 months
|
|
Change from baseline in Health Relates Quality of Life (HRQoL as measured by questionnaires)
Tidsramme: six and 12 months
|
Questionnaires used: Short From 36 (SF-36), Global Mood Scale (GMS), MacNew Heart Disease Quality of Life Instrument (MacNew)
|
six and 12 months
|
|
Number of patients with adverse events (AE; documented)
Tidsramme: six and 12 months
|
six and 12 months
|
|
|
Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications))
Tidsramme: six and 12 months
|
six and 12 months
|
|
|
Change in physical activity level (based on 7-day accelerometry)
Tidsramme: six and 12 months
|
Patients will wear accelerometers for 7 days at baseline, 6 months and 12 months, and the change in physical activity level will be calculated
|
six and 12 months
|
|
Change from baseline in upper and lower body muscular strength (1RM; kg)
Tidsramme: six and 12 months
|
Upper and lower body muscular strength will be measured using a chest press and a leg extension device, respectively.
|
six and 12 months
|
|
Change from baseline in anthropometric measures
Tidsramme: six and 12 months
|
Change from baseline in waist to hip circumference ratio, body mass index (BMI), percent body fat (%) and weight (kg).
|
six and 12 months
|
|
Change from baseline in blood pressure (Systolic and Dystolic;mmHg)
Tidsramme: 6 and 12 months
|
24-hour blood pressure will be measured using a holter BP monitor
|
6 and 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jeffrey W Christle, M.A., Klinikum rechts der Isar
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2931/10
- DRKS00003625 (Registry Identifier: German Clinical Trials Register)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Koronararteriesygdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aorta origin of the coronary artery (AAOCA)Italien
-
University Hospital OstravaRekrutteringIn-Stent Carotis Artery RestenosisTjekkiet
-
Zhejiang Cancer HospitalRekrutteringHepatic Artery Infusion | Levermetastase fra BrystkræftKina
-
University Hospital of PatrasRekrutteringDistal Radial Artery Access (dTRA) | Adgang til radial arterieGrækenland
-
Nanfang Hospital, Southern Medical UniversityAfsluttetLeverskade | Hepatecellular carcinoma | HAIC (Hepatic Artery Infusion Chemotherapy) | TACE(Transkateter arteriel kemioembolisering)Kina
-
Sohag UniversityIkke rekrutterer endnuUmblical artery Doppler under terminsgraviditetEgypten
-
Inova Health Care ServicesBoston Scientific CorporationAfsluttetKoronar angiografi | Transradial adgang | Radial arterie Intimal Medial Tykkelse | Distal Radial Artery Access (dTRA)Forenede Stater
-
IRCCS Policlinico S. DonatoUniversity of Pavia; University of Naples; The Mediterranean Institute for...RekrutteringMyokardieiskæmi | Pludselig hjertedød | Anomal koronararterieoprindelse | Anomal koronararterie, der opstår fra den modsatte sinus | Anomal koronararterie med aorta-oprindelse og forløb mellem de store arterier | Anomalous aorta origin of the coronary artery (AAOCA) | Myokardieiskæmi, Angina Pectoris og andre forholdItalien
-
Baylor College of MedicineAfsluttetLungeblødning | MAPCA - Major Aortopulmonary Collateral ArteryForenede Stater
-
Daewoong Pharmaceutical Co. LTD.UkendtMCA - Middle Cerebral Artery DissektionKorea, Republikken
Kliniske forsøg med combined exercise
-
Encore Medical, L.P.RekrutteringBimalleolære ankelfrakturerForenede Stater
-
Rong WenchaoAfsluttet
-
Shanghai Chest HospitalUkendt
-
Dokuz Eylul UniversityThe Scientific and Technological Research Council of TurkeyRekrutteringObsessiv-kompulsiv lidelse (OCD)Kalkun
-
Wuhan Ammunition Life-tech Co., LtdWuhan UniversityIkke rekrutterer endnuHepatocellulært karcinom
-
Yonsei UniversityTilmelding efter invitation
-
Fudan UniversityIkke rekrutterer endnu
-
Ain Shams UniversityAfsluttetScapholunate Interosseous Ligament Skade | SlliEgypten
-
Tanta UniversityIkke rekrutterer endnuEksotropi | Evaluering af kirurgiske teknikker til at korrigere eksotropi
-
Chestnut Health SystemsNational Institute on Drug Abuse (NIDA)AfsluttetGenopretning | Stofbrugsforstyrrelse (SUD)Forenede Stater