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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Progressive lower limb activities (Chair rise and Step ups); Other: Standard aerobic exercise i.e. low intensity walking

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Armed Forces Institute of Cardiology AFIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive lower limb activities (Chair rise and Step ups); Chair rise and Step ups Exercises	Other: Progressive lower limb activities (Chair rise and Step ups); 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.
Active Comparator: Standard aerobic exercise i.e. low intensity walking; aerobic exercise i.e. low intensity walking	Other: Standard aerobic exercise i.e. low intensity walking; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6th week
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.	6th week
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	6th Week
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.	6th Week
Heart Rate	Changes from the baseline ; Heart rate was measured per minute through cardiac monitor	6th week
Oxygen Saturation	Changes from the baseline ; The saturation of arterial blood with oxygen as measured by pulse oximetry, expressed as percentage.	6th week
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.	6th week

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Iqra Arbab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No