Chronic Liver Disease and CirrhosisNCT05376826
Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance.
A study testing Nurse Led Physical Therapy in people with Chronic Liver Disease and Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 20 to 88 years
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis
- What is being tested?
- Nurse Led Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2021to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prefrail and Frail CLD Patients (MELD <24)
- Follow up of Prefrail and Frail CLD Patients (MELD<24)
- Participants willing for Research
Who cannot join
- Frail Patients who are bedridden
- presence of hepatopulmonary disease
- Presence of neurological defects
- Previous history of Liver Transplantation
- Severe COPD, Heart Failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Liver Disease and Cirrhosis
- Being tested
- Nurse Led Physical Therapy
- Keywords
- Patient Competency, Patient engagement, Physical Performance, CLD, MELD
- Medical subject headings
- Fibrosis, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Led Physical TherapyBehavioural
Nurse Led Physical Therapy in Form of Range of Motion Exercises
| Study group | Role | What they receive |
|---|---|---|
| Prefrail and Frail CLD Patients | Experimental | Nurse- led Physical Therapy include Video based range of Motion Exercises for 10-20 min. Receives: Behavioral: Nurse Led Physical Therapy |
| Control Group | No intervention | Routine Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Nov 2021
- Primary completion14 Nov 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pre-test - Post test Control group design
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonam Ms Kumari, Nursing, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376826
- Sponsor's protocol ID
- ILBS-CLD-02
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05376826
- Acronym / sponsor ID
- ILBS-CLD-02
- Conditions
- Chronic Liver Disease and Cirrhosis
- Keywords
- Patient Competency, Patient engagement, Physical Performance, CLD, MELD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-test - Post test Control group design
| Arm | Type | Receives |
|---|---|---|
| Prefrail and Frail CLD Patients | Experimental | Behavioral: Nurse Led Physical TherapyNurse- led Physical Therapy include Video based range of Motion Exercises for 10-20 min. |
| Control Group | No intervention | –Routine Interventions |
Who may qualify
- Ages
- 20 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prefrail and Frail CLD Patients (MELD <24)
- Follow up of Prefrail and Frail CLD Patients (MELD<24)
- Participants willing for Research
Key exclusion criteria (5 listed)
- Frail Patients who are bedridden
- presence of hepatopulmonary disease
- Presence of neurological defects
- Previous history of Liver Transplantation
- Severe COPD, Heart Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Led Physical TherapyNurse Led Physical Therapy in Form of Range of Motion Exercises | Behavioural | Prefrail and Frail CLD Patients |
Primary outcome
Patient Competency by patient Competency Scale at 1 week
Time frame: 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.
2 secondary outcomes
Patient Engagement by Patient Engagement Scale at 1 week
Time frame: 1 week
Physical Performance by six minute walk test at 1 week
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonam Ms Kumari, Nursing principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Led Physical Therapy in people with Chronic Liver Disease and Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Competency by patient Competency Scale at 1 week (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.