Clinical trial NCT03631524: Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions
Official title: Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deconditioning, Isolation Precautions
Keywords: deconditioning, isolation precautions, telerehabilitation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm single blinded RCT
Primary purpose: TREATMENT

Brief summary: Single blinded Randomised Controlled trial comparing standard therapy to the intervention of up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. Total recruitment: 60 patients.

Detailed description: This is a single blinded randomised control trial. From August 2018 to March 2019, a total of 60 subjects, who match the inclusion exclusion criteria, will be recruited from patients transferred to the SGH Isolation wards.

They will be randomly assigned to control or treatment arm based on a block randomisation strategy predetermined and held by an independent party.

The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. They will be evaluated for motor strength, activity of daily living performance, mood and perceived level of health.

The control arm will be subject to the same assessments as the treatment arm at the start and end of the two week period. They will receive standard care in the ward including physiotherapy as prescribed by the managing team.

The assessors will be blinded to the arm of the study the subjects will be assigned to and will be independent of the terating physiotherapist.

1.1. Hypothesis We propose that for patients with deconditioning after a prolonged period of hospitalization and needing inpatient isolation precautions, that a 2-week course of daily, up to 1-hour long, physiotherapist-developed resistive training exercises will result in a 20% improvement in the motor power and a corresponding improvement in motor functioning and the perceived quality of life compared to a control group receiving standard therapy.

Eligibility criteria: Inclusion Criteria:

* • Able to give consent

  * Admitted to hospital for at least 5 days
  * MMT power grading 2-4/5
  * Isolated for prevention of transmission of MDROs

Exclusion Criteria:

* • Unable or unwilling to consent for the trial

  * Assessed by managing team to be fit for discharge within the next 2 weeks
  * Pregnant women
  * Underlying medical disorders that result in pre-existing lower limb weakness

Primary outcomes:
measure: Manual motor power testing
timeFrame: 2 weeks
Secondary outcomes:
measure: Volume of therapy
timeFrame: 2 weeks
measure: Functional Independence Measure
timeFrame: 2 weeks
measure: Level of anxiety/ depression
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Singhealth Pte Ltd
name: Geoffrey S Samuel, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgan DJ, Diekema DJ, Sepkowitz K, Perencevich EN. Adverse outcomes associated with Contact Precautions: a review of the literature. Am J Infect Control. 2009 Mar;37(2):85-93. doi: 10.1016/j.ajic.2008.04.257.
citation: Ploutz-Snyder LL, Downs M, Ryder J, Hackney K, Scott J, Buxton R, Goetchius E, Crowell B. Integrated resistance and aerobic exercise protects fitness during bed rest. Med Sci Sports Exerc. 2014 Feb;46(2):358-68. doi: 10.1249/MSS.0b013e3182a62f85.