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

NCT05425160 | Completed DMC

• 1 other identifier: Iqra Arbab
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Progressive lower limb activities (Chair rise and Step ups)

EXPERIMENTAL

Chair rise and Step ups Exercises

Other: Progressive lower limb activities (Chair rise and Step ups)

Standard aerobic exercise i.e. low intensity walking

ACTIVE COMPARATOR

aerobic exercise i.e. low intensity walking

Other: Standard aerobic exercise i.e. low intensity walking

Interventions

Progressive lower limb activities (Chair rise and Step ups) OTHER

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.

Progressive lower limb activities (Chair rise and Step ups)

Standard aerobic exercise i.e. low intensity walking OTHER

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

Standard aerobic exercise i.e. low intensity walking

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Armed Forces Institute of Cardiology AFIC

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Muhammad Iqbal Tariq, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: August 15, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)