Exercise Group for Frailty

Phase-Based Progress Estimates
The Ottawa Hospital, Ottawa, CanadaFrailty+9 MoreExercise Group - Behavioral
All Sexes
What conditions do you have?

Study Summary

This trial will compare the effects of a home-based exercise program to no exercise program in people who have had surgery.

Eligible Conditions
  • Frailty
  • Surgery Complications
  • Physical Disabilities

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Participants are asked to reflect on the program during a call the day before surgery.

Day 365
Health System - Emergency department visits
Health System - Hospital re-admissions
Health System - Long-term care admissions
Day 365
All-cause mortality
Day 365
Health-related quality of life
Day 30
Patient-reported disability 30 days after surgery
Day 30
Function - Timed Up and Go Test
Day 30
Function - Katz Index of Activities of Daily Living
Day 30
Safety (Adverse Events)
Day 30
Function - Daily and total step count
Day 30
Function - Falls
Participants are asked to reflect on the program during a call the day before surgery.
Participant Feedback
Day 30
Health System - Discharge position
up to 30 days.
In-hospital complications

Trial Safety

Safety Progress

1 of 3

Side Effects for

Clayton Intra-aural Device (CID) Group
7%Discomfort or Pain
This histogram enumerates side effects from a completed 2009 Phase 1 & 2 trial (NCT00815776) in the Clayton Intra-aural Device (CID) Group ARM group. Side effects include: Discomfort or Pain with 7%, Headache with 5%.

Trial Design

2 Treatment Groups

Control Group
1 of 2
Exercise Group
1 of 2

Active Control

Experimental Treatment

750 Total Participants · 2 Treatment Groups

Primary Treatment: Exercise Group · No Placebo Group · N/A

Exercise Group
Experimental Group · 1 Intervention: Exercise Group · Intervention Types: Behavioral
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Group
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: participants are asked to reflect on the program during a call the day before surgery.

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
535 Previous Clinical Trials
2,511,406 Total Patients Enrolled
3 Trials studying Frailty
350,204 Patients Enrolled for Frailty
Daniel I McIsaac, MD,MPH,FRCPCPrincipal InvestigatorThe Ottawa Hospital Research Institute

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a score of 4 or greater on the Clinical Frailty Scale, which means you may be physically weak or easily exhausted.

Frequently Asked Questions

What is the intended outcome of this investigation?

"This research endeavour aims to gauge patient disability levels after 30 days of post-operative recovery. Additional objectives include surveying mortality rates, safety (adverse events) and health system discharge position. Falls, cardiac or respiratory issues and unplanned healthcare providence will be monitored for the exercise group while control participants must report any falls from enrollment onwards. Unforeseen medical experiences are also scrutinised during enrolment to pre-operation day in the intervention cohort via chart analysis." - Anonymous Online Contributor

Unverified Answer

Are there any limitations on the number of participants in this observational research?

"Indeed, the information available on clinicaltrials.gov reveals that this experiment is recruiting participants currently; it was initially posted on February 24th 2020 and its details were last modified at the end of November 2022. This trial seeks out 750 individuals from a single medical facility." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this trial still open to new applicants?

"Affirmative, the clinicaltrials.gov website states that recruitment is ongoing for this medical trial. It was first listed on February 24th 2020 and most recently edited on November 29th 2022 with a goal of enrolling 750 patients at 1 site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.