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

Primary Purpose

Heart Failure, Old Age; Debility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise Group
Sponsored by
Emine Karaman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Aging, Randomized Controlled Trials (RCT), Nursing, Physical Activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Group

    Control Group

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    Group (empowerment evaluation scale assessment)
    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

    Control Group (empowerment evaluation scale assessment)
    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.

    Full Information

    First Posted
    July 8, 2019
    Last Updated
    July 16, 2019
    Sponsor
    Emine Karaman
    Collaborators
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04022369
    Brief Title
    The Effects of an Exercise Programme for Older Patients With Heart Failure
    Official Title
    The Effects of an Exercise Empowerment Programme for Older Patients With Heart Failure: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    November 30, 2014 (Actual)
    Study Completion Date
    July 6, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Emine Karaman
    Collaborators
    Ege University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Old Age; Debility
    Keywords
    Aging, Randomized Controlled Trials (RCT), Nursing, Physical Activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise Group
    Other Intervention Name(s)
    Control Group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Group (empowerment evaluation scale assessment)
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Control Group (empowerment evaluation scale assessment)
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zehra Çiçek FADILOĞLU, Emertus
    Organizational Affiliation
    Ege University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    IPD Sharing Time Frame
    3 months
    IPD Sharing Access Criteria
    The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure.

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

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