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Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Progressive lower limb activities (Chair rise and Step ups)
Standard aerobic exercise i.e. low intensity walking
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed Preserved ejection Heart Failure Patients
  • Both male and female
  • Age > 60 years
  • Preserved ejection fraction ≥ 45 %
  • HF Duration ≥4 years

Exclusion Criteria:

  • End stage heart failure
  • Acute coronary syndrome
  • Functional status limited due to condition other than heart failure
  • Inability to adhere to study protocols.

Sites / Locations

  • Armed Forces Institute of Cardiology AFIC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive lower limb activities (Chair rise and Step ups)

Standard aerobic exercise i.e. low intensity walking

Arm Description

Chair rise and Step ups Exercises

aerobic exercise i.e. low intensity walking

Outcomes

Primary Outcome Measures

Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Changes from the baseline ; It is a 21 item paper self administered questionnaire. It aims to measure the extent to which HF prevents patients from living the way they would want to. The MLHFQ has been the most widely used instrument for evaluating HRQL in HF patients internationally. Five years ago, the MLHFQ was identified as the questionnaire with the best properties and even now it has the highest scores for reliability, and a good ability to both measure its objective (validity) and detect change over time
Short Physical Performance Battery (SPPB)
Changes from the baseline ; The SPPB is composed of 3 components-standing balance, gait, speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. This protocol consisted of 3 types of progressive activities. Each type contains 2 to 4 tasks, performed in a single attempt. The protocol was performed in 30-minute sessions once a week. It was used to conduct chair rise activity only. Participant was asked to complete five chair stands and the time was noted and scored from 0-4 respectively.
6 Min Walk Distance (6MWT)
Changes from the baseline ; The 6 min walk test (6MWT) is a functional performance measure to examine the functional status of patients with heart and lung disease. This protocol has 1 item only. It was completed in less than 10 minutes. A 6MWT distance of 300 m was also recently found to be a significant predictor of all-cause mortality in a multivariate model examining predictors of clinical outcome in elderly patients with advanced HF. Patients were instructed to cover the greatest distance possible during the allotted time, at a self-determined walking speed, and were allowed to pause and rest when needed. The distance covered was measured by a body-borne pedometer with which the total number of steps taken during the 6MWT were used to calculate the 6MWT distance using the equation reported by Roul et al. (d ¼ y × 10 m/x; where d ¼ distance ambulated in m; y ¼ total number of steps during 6MWT; and x ¼ number of steps for each subject to cover 10 m
Fatigue Assessment Scale (FAS)
Changes from the baseline ; The FAS is a 10-item scale evaluating symptoms of chronic fatigue. The FAS is a self-report, paperand-pencil measure requiring approximately 2 min for administration. The scale has been validated in a population of both male and female. Each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Heart Rate
Changes from the baseline ; Heart rate was measured per minute through cardiac monitor
Oxygen Saturation
Changes from the baseline ; The saturation of arterial blood with oxygen as measured by pulse oximetry, expressed as percentage.
VO2 Max
Changes from the baseline ;The maximum or optimum rate at which the heart, lungs and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2022
Last Updated
January 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05425160
Brief Title
Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients
Official Title
Effects of Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
To determine the effects of Chair Rise and Step ups on cardiopulmonary parameters among Preserved ejection Heart Failure Patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive lower limb activities (Chair rise and Step ups)
Arm Type
Experimental
Arm Description
Chair rise and Step ups Exercises
Arm Title
Standard aerobic exercise i.e. low intensity walking
Arm Type
Active Comparator
Arm Description
aerobic exercise i.e. low intensity walking
Intervention Type
Other
Intervention Name(s)
Progressive lower limb activities (Chair rise and Step ups)
Intervention Description
Progressive lower limb activities (Chair rise and Step ups) were be carried out weekly for upto 6 weeks. Before initiation, cardiopulmonary parameters i.e. Heart rate, oxygen saturation, cardiac output and stroke volume were measured at baseline and later at the termination of activity on each week. Initially, five repeated chair rise were conducted through SPPB and the time was noted to complete the task and step ups through 6MWD for a total period of 30 min. Lastly, fatigue component was assessed via FAS.
Intervention Type
Other
Intervention Name(s)
Standard aerobic exercise i.e. low intensity walking
Intervention Description
Standard aerobic exercise i.e. low intensity walking were conducted in both the groups. Follow up phone calls and 1 OPD visit were scheduled accordingly
Primary Outcome Measure Information:
Title
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Description
Changes from the baseline ; It is a 21 item paper self administered questionnaire. It aims to measure the extent to which HF prevents patients from living the way they would want to. The MLHFQ has been the most widely used instrument for evaluating HRQL in HF patients internationally. Five years ago, the MLHFQ was identified as the questionnaire with the best properties and even now it has the highest scores for reliability, and a good ability to both measure its objective (validity) and detect change over time
Time Frame
6th week
Title
Short Physical Performance Battery (SPPB)
Description
Changes from the baseline ; The SPPB is composed of 3 components-standing balance, gait, speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. This protocol consisted of 3 types of progressive activities. Each type contains 2 to 4 tasks, performed in a single attempt. The protocol was performed in 30-minute sessions once a week. It was used to conduct chair rise activity only. Participant was asked to complete five chair stands and the time was noted and scored from 0-4 respectively.
Time Frame
6th week
Title
6 Min Walk Distance (6MWT)
Description
Changes from the baseline ; The 6 min walk test (6MWT) is a functional performance measure to examine the functional status of patients with heart and lung disease. This protocol has 1 item only. It was completed in less than 10 minutes. A 6MWT distance of 300 m was also recently found to be a significant predictor of all-cause mortality in a multivariate model examining predictors of clinical outcome in elderly patients with advanced HF. Patients were instructed to cover the greatest distance possible during the allotted time, at a self-determined walking speed, and were allowed to pause and rest when needed. The distance covered was measured by a body-borne pedometer with which the total number of steps taken during the 6MWT were used to calculate the 6MWT distance using the equation reported by Roul et al. (d ¼ y × 10 m/x; where d ¼ distance ambulated in m; y ¼ total number of steps during 6MWT; and x ¼ number of steps for each subject to cover 10 m
Time Frame
6th Week
Title
Fatigue Assessment Scale (FAS)
Description
Changes from the baseline ; The FAS is a 10-item scale evaluating symptoms of chronic fatigue. The FAS is a self-report, paperand-pencil measure requiring approximately 2 min for administration. The scale has been validated in a population of both male and female. Each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Time Frame
6th Week
Title
Heart Rate
Description
Changes from the baseline ; Heart rate was measured per minute through cardiac monitor
Time Frame
6th week
Title
Oxygen Saturation
Description
Changes from the baseline ; The saturation of arterial blood with oxygen as measured by pulse oximetry, expressed as percentage.
Time Frame
6th week
Title
VO2 Max
Description
Changes from the baseline ;The maximum or optimum rate at which the heart, lungs and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed Preserved ejection Heart Failure Patients Both male and female Age > 60 years Preserved ejection fraction ≥ 45 % HF Duration ≥4 years Exclusion Criteria: End stage heart failure Acute coronary syndrome Functional status limited due to condition other than heart failure Inability to adhere to study protocols.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Institute of Cardiology AFIC
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients

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