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The Effects of an Exercise Programme for Older Patients With Heart Failure

16. července 2019 aktualizováno: Emine Karaman

The Effects of an Exercise Empowerment Programme for Older Patients With Heart Failure: A Randomized Controlled Trial

Patients with heart failure have decreased exercise tolerance, balance problems, and fall risks. The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure. This randomized, controlled study including pre-test/post-test and the measurements were performed between January-November 2014 at a university hospital in Izmir, Turkey. Intervention group (n = 11) and control group (n = 10) participated in the research. The intervention group received 45-60 minute individual training and 12 weeks of individual follow-up. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. Patients in the control group did not receive any intervention except for their routine treatment. Data were collected before the education of exercise and after 12 weeks; sociodemographic data questionnaire, pedometer, accelerometer, Berg Balance Scale, HF Empowerment Scale, estimated weekly exercise monitoring form and exercise booklet had been utilised. The SPSS statistical package program was used to analyze the data.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Patients with heart failure have decreased exercise tolerance, balance problems, and fall risks. The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure.

This randomized, controlled study including pre-test/post-test and the measurements were performed between January-November 2014 at a university hospital in Izmir, Turkey. Intervention group (n = 11) and control group (n = 10) participated in the research. The intervention group received 45-60 minute individual training and 12 weeks of individual follow-up. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. Patients in the control group did not receive any intervention except for their routine treatment. Data were collected before the education of exercise and after 12 weeks; sociodemographic data questionnaire, pedometer, accelerometer, Berg Balance Scale, HF Empowerment Scale, estimated weekly exercise monitoring form and exercise booklet had been utilised. The SPSS statistical package program was used to analyze the data.

Typ studie

Intervenční

Zápis (Aktuální)

21

Fáze

  • Nelze použít

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • were aged 60 years or older
  • independent
  • literate
  • able to communicate verbally
  • participating voluntarly in the study

Exclusion Criteria:

  • were having a diagnosis of psychiatric illness
  • a visual or auditory impairment
  • previously participated in another exercise program
  • any contraindication to exercise (uncontrolled arrhythmia, hypertension and metabolic illness, ejection fraction)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Exercise Group
The intervention group received 45-60 minute of individual training and a handbook for the exercise program was given. These patients were followed for a total of 12 weeks. The exercise program was developed by reviewing the literature part on physical activity for senior citizens with heart failure. Education program based on Empowerment model. Weekly motivational telephone interviews were conducted with the patients, and the home visits and telephone interviews were repeated when belived necessary. The purpose of the study were explained to all individuals involved in the study. Body movements, balance levels, exercise durations, and strengths of individuals before exercise program and after exercise program were evaluated. A booklet demonstrating the exercises was given to the patients to enhance their understanding, and they were allowed to ask questions about the exercise program during the training.
Behaviorální: Exercise Group
The intervention group received 45-60 minute of individual training and a handbook for the exercise program was given. These patients were followed for a total of 12 weeks. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. The exercise program was developed by reviewing the literature part on physical activity for senior citizens with heart failure. The program was established on evidence-based recommendations for the cardiac rehabilitation of patients with HF. Each session included warm-up and cool-down exercises, moderate walking, and balance exercises.
Ostatní jména:
  • Kontrolní skupina
Žádný zásah: Control Group
The patients in the control group continued their standard treatment and care. Data collection forms were applied to the patients in the control group at the first month and 12 weeks after discharge. After the study was completed, all patients in the control group were provided with home-based exercise training booklets.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Group (empowerment evaluation scale assessment)
Časové okno: 3 months
Old patients were observed and evaluated daily activities during 12 weeks. The exercise program was established on evidence-based recommendations for patients with Heart Failure (HF). Empowerment level of individuals before and after exercise program were evaluated. Empowerment is a model aiming to protect patients' rights and develop the quality of care. This model is aimed at giving individuals a feeling of success and improving their self image, and is intended to make necessary lifestyle changes easier and more lasting. Subscales of the empowerment are "Managing the Psychosocial Aspects of Heart Failure", "Assessing Dissatisfaction and Readiness to Change" and "Setting and Achieving Heart Failure Goals". The Scale evaluated has 28 items and five-way likert-type. Scores range from 28 to 140, scores of 28-65 classified as low, 66-103 as medium, and 104-140 as high.
3 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Control Group (empowerment evaluation scale assessment)
Časové okno: 3 months
The patients in the control group continued their routine treatment and daily living activities. These patients were observed and evaluated daily activities during 12 weeks. Empowerment level of the individuals before and after 12 weeks were evaluated. Empowerment is a model aiming to protect patients' rights and develop the quality of care. This model is aimed at giving individuals a feeling of success and improving their self image, and is intended to make necessary lifestyle changes easier and more lasting. Subscales of the empowerment are "Managing the Psychosocial Aspects of Heart Failure", "Assessing Dissatisfaction and Readiness to Change" and "Setting and Achieving Heart Failure Goals". The Scale evaluated has 28 items and five-way likert-type. Scores range from 28 to 140, scores of 28-65 classified as low, 66-103 as medium, and 104-140 as high.
3 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Emine Karaman

Spolupracovníci

Ege University

Vyšetřovatelé

  • Ředitel studie: Zehra Çiçek FADILOĞLU, Emertus, Ege University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2014

Primární dokončení (Aktuální)

30. listopadu 2014

Dokončení studie (Aktuální)

6. července 2015

Termíny zápisu do studia

První předloženo

8. července 2019

První předloženo, které splnilo kritéria kontroly kvality

16. července 2019

První zveřejněno (Aktuální)

17. července 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. července 2019

Naposledy ověřeno

1. července 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 12-9/7

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

The intervention group received 45-60 minute of individual training and a handbook for the exercise program was given. These patients were followed for a total of 12 weeks. The exercise program was developed by reviewing the literature part on physical activity for senior citizens with heart failure. Education program based on Empowerment model. Weekly motivational telephone interviews were conducted with the patients, and the home visits and telephone interviews were repeated when belived necessary. The purpose of the study were explained to all individuals involved in the study. Body movements, balance levels, exercise durations, and strengths of individuals before exercise program and after exercise program were evaluated. A booklet demonstrating the exercises was given to the patients to enhance their understanding, and they were allowed to ask questions about the exercise program during the training.

Časový rámec sdílení IPD

3 months

Kritéria přístupu pro sdílení IPD

The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Podmínky

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Doplňky stravy

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Místa

3
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