Primary Biliary Cholangitis Clinical Trial
Official title:
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
A prospective, single centre, single-arm, pilot study investigating the safety and efficacy of a 12-week remotely-monitored home-based exercise program in patients with refractory fatigue (based on PBC-40 Quality of Life measure) secondary to Primary Biliary Cirrhosis.
Recruitment from the research nurse-led PBC clinic: Eligibility screen followed by
recruitment letters being sent to patients.
The outpatient clinic review by the liver specialist physiotherapist (week 0):
Patients will undergo a baseline assessment of quality of life, anthropometry, functional
capacity (with validated tools including the incremental shuttle walk test and short
performance battery test) and exercise tolerance. At the same visit, patients will be
prescribed and trained to perform the individualised Home-based Exercise Program. Patients
will be provided with an accelerometer to assess daily step count and a symptoms/side effects
diary.
Six weeks of telephone support (weeks 0-6):
Patients will be telephoned weekly over a period of 6 weeks, in order to evaluate compliance
with therapy and any difficulties encountered. At each phone call, the daily step count and
the intensity of the resistance-exercises will be adjusted to the patients ability.
The outpatient clinic review by the liver specialist physiotherapist (week 6 +/- 5 days):
Reassessment of baseline parameters of quality of life, functionality and exercise tolerance;
and modification of step count targets and resistance-exercise intervention as needed.
The outpatient clinic review by the liver specialist physiotherapist (week 12 +/- 5 days):
Reassessment of baseline parameters of quality of life, functionality and exercise tolerance;
and modification of step count targets and resistance-exercise intervention as needed.
Validate the efficacy of exercise intervention: Given that the goal is to improve
fatigue-related symptoms and thus patient quality of life, the investigators will determine
the interim efficacy and longevity of intervention using a multi-modal patient-reported
outcome approach. This will principally be through changes in validated quality of life (QoL)
scoring measures at baseline and during sequential study visits; including the fatigue domain
of the PBC-40 QoL measure (primary outcome measure), in addition to the relevant PBC-40
domains of cognitive, social, emotional and overall symptom burden; the Hospital Anxiety and
Depression Scale (HADS); Epworth Sleepiness Scale to assess daytime somnolence;
Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire
(PROMIS-HAQ®) to assess functional status, and the Cognitive Failure questionnaire (COGFAIL)
to determine cognitive functionality.
All data will be collated onto a standardised clinical case record form. Outcomes will be
audited after 6 months to determine whether the intervention has proven beneficial to
patients, and whether improvements in functional status correlate with changes in fatigue and
QoL scores
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