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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425160
• Other study ID #: Iqra Arbab
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: January 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Cardiology AFIC	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

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