Treatment for Old Age; Debility

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arthritis Research Canada, Richmond, Canada
Old Age; Debility+2 More
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new coaching approach to delivering the Otago Exercise Program can reduce falls in older adults.

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Eligible Conditions

  • Old Age; Debility
  • Fall

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 5 secondary outcomes in patients with Old Age; Debility. Measurement will happen over the course of During the 12-month intervention.

12 months
Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)
24 months
Older Adult-Level Outcome - Average Daily Step Count
Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)
Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)
Month 24
Older Adult-Level Outcome - Number of Falls
During the 12-month intervention
Older Adult-Level Outcome - rate of adherence to the Otago Exercise Program (OEP)
Physiotherapist-level outcome - Brief Action Planning (BAP) Scores

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Otago Exercise Programme+ Intervention Group (OEP+)
1 of 2
Otago Exercise Programme Group (OEP)
1 of 2
Active Control
Non-Treatment Group

This trial requires 360 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Otago Exercise Programme+ Intervention Group (OEP+)Physiotherapists receive OEP training, a 2 hour workshop on the coaching protocol using the OEP app, and online training on the Brief Action Plan Approach with 2 telephone practice sessions with an experienced Brief Action Plan counsellor. Each PT will deliver exercise program to 8 older adults. PTs will help older adults to set-up OEP app and Fitbit. PT will return bi-weekly over the course of two months (four visits total) for follow-up. During months 3-5, PTs will call participants three times times to review the exercise plan. The last visit will be an at-home visit which will occur 6 months after the initial visit. Between Months 7-12, PTs will continue to a phone call follow-up once a month to review the exercise routine. Older Adults will receive an OEP manual and cuff weights to be used with the strength training. They will also have access to the OEP app which allows the PT to prescribe exercises and record the participant's exercise goal.
Otago Exercise Programme Group (OEP)Physiotherapists receive OEP Training and a 2 hour workshop on just the counselling protocol. Each PT will deliver exercise program to 8 older adults. PTs will help older adults to set-up the Fitbit. For the first two months, PTs will provide bi-weekly home visits. During months 3-5, PTs will call participants three times times to review the exercise plan. The last visit will be an at-home visit which will occur 6 months after the initial visit. Older Adults will receive an OEP manual and cuff weights to be used with the strength training. They will also receive a Fitbit. Between Months 7-12, older adults will receive follow-up phone calls from the research staff.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during the 12 months after the intervention (i.e., 13-24 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during the 12 months after the intervention (i.e., 13-24 months) for reporting.

Who is running the study

Principal Investigator
L. L.
Linda Li, Principal Investigator
University of British Columbia

Closest Location

Arthritis Research Canada - Richmond, Canada

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
are able to walk three meters with or without an assistive device
have a Mini-Mental State Examination score > 24/30
have a Physiological Profile Assessment composite score of at least 1.0 standard deviation above age-normative value or have a Timed Up and Go test > 15 seconds, or had one additional non-syncopal fall in the previous 12 months
live in an area served by Vancouver Coastal Health
understand, speak, and read English proficiently
self-report a non-syncopal fall corroborated by an informant, in the previous six months
over 70 years of age
have access to a mobile device
are willing to have their OEP sessions audio-recorded
able to provide written informed consent

Patient Q&A Section

How many people get frailty a year in the United States?

"Frailty is a common and growing condition affecting millions of older adults and their families. The number of cases has grown substantially with a doubling of deaths from cardiovascular, renal and respiratory disease between 1990 and 2013. The number of new cases rose rapidly from 7,100 patients in 2001 to 55,000 in 2013." - Anonymous Online Contributor

Unverified Answer

What causes frailty?

"In this prospective study, the occurrence of frailty was not predicted by any of the variables in any of the groups. On the basis of the above, we feel that a definition of frailty should be based on the presence or absence of frailty at baseline. Further efforts to identify factors contributing to frailty are required." - Anonymous Online Contributor

Unverified Answer

Can frailty be cured?

"The concept of frail status has been used to illustrate how to conceptualize what the ultimate goal of a disease management program should be and not focussing on curing the disease. It is important to acknowledge that this program aimed at improving the current living conditions of aged and frail people could not only affect frailty status, but also their actual quality of life, health-span and prognosis of clinical events such as falls, hospitalization, and death." - Anonymous Online Contributor

Unverified Answer

What are common treatments for frailty?

"What is common for all people living at home with frailty is the help to live independently in daily matters as an active member of your community. It allows elderly people to remain an active member in their community and stay independent. Many different treatments are available. It has been shown in many studies that exercise therapy could reduce frailty of elderly people, and enhance mental and physical functioning. Also, it is essential for elderly people to be independent of their community for the preservation of their living and community. The key is to empower them to do things they can do without relying on others." - Anonymous Online Contributor

Unverified Answer

What is frailty?

"Older adults are at higher risk for frailty than younger older adults. Frailty is associated with adverse functional outcomes. More research is needed to better delineate exactly how and when frailty should be evaluated to identify clinically important frailty." - Anonymous Online Contributor

Unverified Answer

What are the signs of frailty?

"Frailty is a state of low physical and mental health. It describes a group of elderly that have specific health risk factors and it is an identifiable state of low health that can be measured, assessed, and treated on a population-wide basis. The concept of frailty was developed in the context of health care systems and care pathways where it occurs, such as end-of-life care in older adults. The concept also has great potential to be used in health promotion and public health programs." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"The number of treatments used for managing patients with dementia is relatively small. The use of multiple treatments for dementia is common, and the likelihood of multiple treatments increases with clinical severity. Therefore, patients with dementia would be best served by the development of quality standard guidelines for dementia management. There is no information about when a patient should stop taking their dementia medication. This should be based on the need for medication to achieve therapeutic objectives. The use of multiple medications should be carefully evaluated at least prior to the initiation of a new medication." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with frailty?

"In the present study of frail elderly men, treatment did not modify QoL. Results from a recent paper suggest that there appears no reason to consider frailty alone, rather combinations of specific impairments and treatments that target these impairments are required to improve QoL in frail older adults." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating frailty?

"Data from a recent study of this research showed that an assessment of frailty is important for the management of frail older adults. In addition, this analysis showed that the use of exercise as well as oral anti-oxidant therapy were the best interventions to improve health. Data from a recent study can help improve our understanding of frailty in the community, help identify individuals who will benefit from intervention trials, and encourage health care professionals to evaluate and treat frailty in their patients." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"Mild to moderate pain was the most common adverse event (>1% of people treated) during [treatment for ALS]. Mild to moderate fatigue and sleep disturbances occurred most commonly (>1%) during adjuvant therapy and more commonly (>1%) during treatment for ALS. Severe side effects were rare. There is no evidence that either side effects occur more often than other side effects." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"In most European countries patients with frailty (at least 3 of 4 criteria) are generally treated mainly with combined treatments, although in a few cases patients with multiple diseases could also be considered for combined therapy." - Anonymous Online Contributor

Unverified Answer

How serious can frailty be?

"There are a number of risk factors for frailty, and more awareness is needed to prevent and treat this condition. Frailty can be a predictor of adverse outcomes such as [mortality or hospitalization(s)] and can also delay a number of treatments such as medication therapy and rehabilitation." - 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.
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