Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions (IsoRehab2018)

• ClinicalTrials.gov Identifier: NCT03631524
• Recruitment Status: Unknown
• First Posted: August 15, 2018
• Last Update Posted: November 9, 2018
• Sponsor: Singapore General Hospital
• Collaborator: National Medical Research Council (NMRC), Singapore
• Information provided by (Responsible Party): Geoffrey Sithamparapillai Samuel, Singapore General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Deconditioning, Isolation Precautions	Device: Telerehabilitation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two arm single blinded RCT
• Masking: Single (Outcomes Assessor)
• Masking Description: Block Randomisation, Initial and final outcome assessors blinded to treatment arm
• Primary Purpose: Treatment
• Official Title: Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions
• Estimated Study Start Date: November 15, 2018
• Estimated Primary Completion Date: December 20, 2019
• Estimated Study Completion Date: December 20, 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Conventional therapy; 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
Experimental: Intervention arm; 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.	Device: Telerehabilitation; 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.

Outcome Measures

Primary Outcome Measures :

1. Manual motor power testing [ Time Frame: 2 weeks ]

   To assess change in the motor function level (as determined by

   1. Medical Research Council (MRC) Manual Muscle Testing (MMT)) at the end of 2 weeks of assessment.
   2. To assess change of quadriceps strength using a handheld dynamometer at the end of 2 weeks of assessment

Secondary Outcome Measures :

1. Volume of therapy [ Time Frame: 2 weeks ]
   The number of repetitions of each exercise will be used as corraborative evidence of progress during therapy.
2. Functional Independence Measure [ Time Frame: 2 weeks ]

   The FIM Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living based on their score in 18 categories (13 motor and 5 cognitive function items). Each category or item is rated on a 7-point scale (1 = total assistance required, 7 = fully independent).

   Coster, W. J., Haley, S. M., et al. (2006). "Measuring patient-reported outcomes after discharge from inpatient rehabilitation settings." J Rehabil Med 38(4): 237-242.

3. Level of anxiety/ depression [ Time Frame: 2 weeks ]

   Hospital Anxiety and Depression Score. The HADS is a fourteen item clinical assessment scale to assess levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression.

   Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses an ordinal scale.

   A number of researchers have explored HADS data to establish the cut-off points for diagnosis of anxiety or depression. A systematic review of a large number of studies identified a cut-off point of 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Geoffrey S Samuel, MBBS; +6597607935; geoffrey.sithamparapillai.samuel@singhealth.com.sg

Sponsors and Collaborators

Singapore General Hospital

National Medical Research Council (NMRC), Singapore

Investigators

• Principal Investigator: Geoffrey S Samuel, MBBS; Singhealth Pte Ltd

More Information

Publications:

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. Review.

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.

• Responsible Party: Geoffrey Sithamparapillai Samuel, Consultant, Department of Rehabilitation Medicine, Singapore General Hospital
• ClinicalTrials.gov Identifier: NCT03631524
• Other Study ID Numbers: 2017/2994
• First Posted: August 15, 2018
• Last Update Posted: November 9, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Geoffrey Sithamparapillai Samuel, Singapore General Hospital:

deconditioning, isolation precautions, telerehabilitation