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

Sponsor
Emine Karaman (Other)
Overall Status
Completed
CT.gov ID
NCT04022369
Collaborator
Ege University (Other)
21
2
18.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise Group
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effects of an Exercise Empowerment Programme for Older Patients With Heart Failure: A Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Nov 30, 2014
Actual Study Completion Date :
Jul 6, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.
Other Names:
  • Control Group
  • No Intervention: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Group (empowerment evaluation scale assessment) [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.

    Secondary Outcome Measures

    1. Control Group (empowerment evaluation scale assessment) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Emine Karaman
    • Ege University

    Investigators

    • Study Director: Zehra Çiçek FADILOĞLU, Emertus, Ege University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emine Karaman, Research Assistant Ms., PhD, Ege University
    ClinicalTrials.gov Identifier:
    NCT04022369
    Other Study ID Numbers:
    • 12-9/7
    First Posted:
    Jul 17, 2019
    Last Update Posted:
    Jul 17, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emine Karaman, Research Assistant Ms., PhD, Ege University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 17, 2019