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

Chronic Liver Disease and Cirrhosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376826
• Other study ID #: ILBS-CLD-02
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 5, 2021

Study information

• Verified date: October 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 5, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease and Cirrhosis
• Liver Diseases

Intervention

Behavioral:
• Nurse Led Physical Therapy
Nurse Led Physical Therapy in Form of Range of Motion Exercises

Locations

Country	Name	City	State
India	Sonam Kumari	New delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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