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

Primary Purpose

Chronic Liver Disease and Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nurse Led Physical Therapy
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Liver Disease and Cirrhosis focused on measuring Patient Competency, Patient engagement, Physical Performance, CLD, MELD

Eligibility Criteria

20 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonam Kumari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prefrail and Frail CLD Patients

Control Group

Arm Description

Nurse- led Physical Therapy include Video based range of Motion Exercises for 10-20 min.

Routine Interventions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 11, 2021
Last Updated
May 16, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05376826
Brief Title
Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 14, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease and Cirrhosis
Keywords
Patient Competency, Patient engagement, Physical Performance, CLD, MELD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre-test - Post test Control group design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prefrail and Frail CLD Patients
Arm Type
Experimental
Arm Description
Nurse- led Physical Therapy include Video based range of Motion Exercises for 10-20 min.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine Interventions
Intervention Type
Behavioral
Intervention Name(s)
Nurse Led Physical Therapy
Intervention Description
Nurse Led Physical Therapy in Form of Range of Motion Exercises
Primary Outcome Measure Information:
Title
Patient Competency by patient Competency Scale at 1 week
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Patient Engagement by Patient Engagement Scale at 1 week
Description
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.
Time Frame
1 week
Title
Physical Performance by six minute walk test at 1 week
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonam Ms Kumari, Nursing
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonam Kumari
City
New delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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