Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance.

A Study to Assess the Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance Among CLD Patients With Physical Frailty.

Due to Prolonged diseased Condition, Patients are not able to care for themselves and even avoid movement their range of motion is limited which may develop frailty among Liver disease Patients.

This Study aims at assessing Engagement, Competency and Physical Performance of Physical Frail Chronic Liver disease Patients before and after Nurse led Physical therapy.

Besides these Parameters effect of Intervention on Physical frailty will also be assessed.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease and Cirrhosis
• Intervention / Treatment: Behavioral: Nurse Led Physical Therapy

Detailed Description

Research Approach: Quantitative Study Research design: Quasi Experimental Research design ( Pre-test - Post test Control group design) Setting: Study is planned on OPD patients of ILBS, New Delhi. Sampling Technique: Random Allocation in Experiment and Control group after matching for age and gender Sample size: 80 Patients Variables: Independent variable- Nurse-led Physical therapy Dependent Variable- Patient Competency, Patient Engagement, Physical Performance.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New delhi, Delhi, India, 110070
      • Sonam Kumari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Prefrail and Frail CLD Patients (MELD <24)
• Follow up of Prefrail and Frail CLD Patients (MELD<24)
• Participants willing for Research

Exclusion Criteria:

• Frail Patients who are bedridden
• presence of hepatopulmonary disease
• Presence of neurological defects
• Previous history of Liver Transplantation
• Severe COPD, Heart Failure

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prefrail and Frail CLD Patients; Nurse- led Physical Therapy include Video based range of Motion Exercises for 10-20 min.	Behavioral: Nurse Led Physical Therapy; Nurse Led Physical Therapy in Form of Range of Motion Exercises
No Intervention: Control Group; Routine Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Competency by patient Competency Scale at 1 week	Compare Patient Competency using patient Competency Scale. The total score of this scale ranges from 0-84 with minimum score 28 and maximum score 84. Higher scores mean a highly competent score.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Engagement by Patient Engagement Scale at 1 week	Patient Engagement using Patient Engagement Scale. The total score of this scale ranges from 10-40 with minimum score 10 and maximum score 40. Higher scores mean a highly engaged.	1 week
Physical Performance by six minute walk test at 1 week	Physical Performance using six minute walk test in Physically Frail Chronic Liver disease patients before and after Physical Therapy. The distance covered measures physical performance, where distance more than 300 meter means normal physical performance and less than or equal to 300 meter means low physical performance.	1 week

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Sonam Ms Kumari, Nursing, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 14, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: CLD; Physical Performance; Patient engagement; Patient Competency; MELD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ILBS-CLD-02

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