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

16 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Altri nomi:
  • Gruppo di controllo
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Group (empowerment evaluation scale assessment)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Control Group (empowerment evaluation scale assessment)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Direttore dello studio: Zehra Çiçek FADILOĞLU, Emertus, Ege University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2014

Completamento primario (Effettivo)

30 novembre 2014

Completamento dello studio (Effettivo)

6 luglio 2015

Date di iscrizione allo studio

Primo inviato

8 luglio 2019

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2019

Primo Inserito (Effettivo)

17 luglio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano 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.

Periodo di condivisione IPD

3 months

Criteri di accesso alla condivisione 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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