NCT05376826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
Last Updated

May 17, 2022

Status Verified

October 1, 2021

Enrollment Period

13 days

First QC Date

October 11, 2021

Last Update Submit

May 16, 2022

Conditions

Keywords

Patient CompetencyPatient engagementPhysical PerformanceCLDMELD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient Engagement by Patient Engagement Scale at 1 week

    1 week

  • Physical Performance by six minute walk test at 1 week

    1 week

Study Arms (2)

Prefrail and Frail CLD Patients

EXPERIMENTAL

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

Behavioral: Nurse Led Physical Therapy

Control Group

NO INTERVENTION

Routine Interventions

Interventions

Nurse Led Physical Therapy in Form of Range of Motion Exercises

Prefrail and Frail CLD Patients

Eligibility Criteria

Age20 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonam Kumari

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

FibrosisPatient Participation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sonam Ms Kumari, Nursing

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Pre-test - Post test Control group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

May 17, 2022

Study Start

November 1, 2021

Primary Completion

November 14, 2021

Study Completion

December 5, 2021

Last Updated

May 17, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations