Deconditioning, Isolation Precautions Clinical Trial
— IsoRehab2018Official title:
Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | December 20, 2019 |
| Est. primary completion date | December 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 99 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Singapore General Hospital | National Medical Research Council (NMRC), Singapore |
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Manual motor power testing | To assess change in the motor function level (as determined by Medical Research Council (MRC) Manual Muscle Testing (MMT)) at the end of 2 weeks of assessment. To assess change of quadriceps strength using a handheld dynamometer at the end of 2 weeks of assessment |
2 weeks | |
| Secondary | Volume of therapy | The number of repetitions of each exercise will be used as corraborative evidence of progress during therapy. | 2 weeks | |
| Secondary | Functional Independence Measure | 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. |
2 weeks | |
| Secondary | Level of anxiety/ depression | 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. |
2 weeks |