NCT03631524

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

August 3, 2018

Last Update Submit

November 8, 2018

Conditions

Deconditioning, Isolation Precautions

Keywords

deconditioning, isolation precautions, telerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Manual motor power testing

    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

    2 weeks

Secondary Outcomes (3)

  • Volume of therapy

    2 weeks

  • Functional Independence Measure

    2 weeks

  • Level of anxiety/ depression

    2 weeks

Study Arms (2)

Conventional therapy

NO INTERVENTION

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

Intervention arm

EXPERIMENTAL

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

Interventions

TelerehabilitationDEVICE

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.

Intervention arm

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 19249637BACKGROUND

  • 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.

    PMID: 24441215BACKGROUND

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Geoffrey S Samuel, MBBS

    Singhealth Pte Ltd

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey S Samuel, MBBS

CONTACT

+6597607935geoffrey.sithamparapillai.samuel@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Block Randomisation, Initial and final outcome assessors blinded to treatment arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arm single blinded RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Department of Rehabilitation Medicine

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 15, 2018

Study Start

November 15, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

November 9, 2018

Record last verified: 2018-11