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FragilityERFNCT02952443

Exercise Intervention to Reverse Frailty

An observational study of Fragility, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to evaluate a multi-component exercise intervention as an effective therapy to reverse pre-frailty phenotype in females age 65 or older. Participants will be screened for frailty phenotype using the Cardiac Health Study - Frailty Index (CHS); the Clinical Frailty Scale (CFS); and a… Read more about this study

Who is it for?
Ages 65 to 95 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fragility
What is being tested?
Exercise
How many people
50 participants
Where
1 siteCanada
Study dates
Nov 2016to Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 95 years
  • Women only
  • Healthy volunteers accepted
  • Older adult

Study population: This investigation will determine if frailty can be reversed through a multi-component exercise program. Females (65+ years of age) will be evaluated for the pre-frailty phenotype using the CHS and for characteristics of "vulnerable" and/or "mildly frail" using the CFS. To confirm frailty status, gait speed will be evaluated. A normal gait speed of 1-1.5 meters/second is associated with persons expressing the pre-frailty phenotype. Females who are pre-frail will randomized into the study as this demographic is at a critical-point of physical transition between frailty phenotypes. The objective is to reverse the frailty phenotype (pre-frail becomes non-frail) using a 16-week multi-component exercise program.

Who may be able to join

  • Female
  • 65-95 years of age
  • Free of any serious injury in the last 6 months
  • Deemed to express the pre-frailty phenotype, meaning they are classified as: Pre-frail according to the CHS and "Vulnerable" and/or "Mildly Frail" according to the CFS
  • Confirmation of pre-frailty based-upon walking speed of 1.0-1.5 meters/second
  • Assessed as healthy for exercise according to responses from the PAR-Q+
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  • Are consider safe for exercise based on the evaluation by a Certified Exercise Physiologist (CEP).
  • Do not have any cognitive impairment, a score of ≥26 (total possible score 30) indicates normal cognitive function as measured by MoCA tool
  • Participants must be able to speak and read English fluently

Who cannot join

  • Male
  • Below 65 years of age or above 95
  • Have suffered a serious injury in the last 6 months
  • Not deemed pre-frail based on scores from the CHS and CFS
  • Walking speed slower or faster than 1.0-1.5 m/s
  • Assessed as unhealthy for exercise according to responses from the PAR-Q+
  • Are consider unsafe for exercise based on the evaluation of the CSEP-CEP
  • Have possible cognitive impairment as measured by the MoCA tool (score <26)

Trial locations and contacts

1 site in 1 country.

Gareth R Jones, PhD contact

2508078102

gareth.jones@ubc.ca

Canada1 site, 1 recruiting
  • Healthy Exercise and Aging Lab - UBC Okanagan

    Kelwona, British Columbia, V1V 1V7

    Gareth R Jones, PhD, 2508078102, gareth.jones@ubc.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Multi-Component Exercise Intervention for Pre-Frail Older Females.

The objective of this study is to evaluate a multi-component exercise intervention as an effective therapy to reverse pre-frailty phenotype in females age 65 or older. Participants will be screened for frailty phenotype using the Cardiac Health Study - Frailty Index (CHS); the Clinical Frailty Scale (CFS); and a measure of self-paced normal walking speed. Participants undergo baseline evaluation to determine frailty phenotype and then those females who meet the pre-frailty criteria are randomized into one of two groups; 1) Multi-component exercise program, or 2) A control group who receives a monthly newsletter on tips for successful aging. The exercise group will participate in multi-component exercise program which will emphasize resistance training but also include aerobic, balance and flexibility components 3 times a week at 45 to 60 minutes/session for 16 consecutive weeks. The control group will be asked to maintain normal daily-living habits for the duration of the 16-week study.

Read the detailed description

Frailty is term widely used to denote a multidimensional syndrome associated with the loss of physical and cognitive reserve capacity that makes an individual vulnerable to cumulative clinical health conditions. The level of frailty can be classified as one of three phenotypes (non-frail; pre-frail, frail) using the Cardiac Health Study frailty index (CHS). The CHS assesses the number of physical deficits expressed by an individual. These deficits include (unexplained weight loss, poor grip strength, feelings of exhaustion, slowed gait, and low levels of physical activity). An individual who exhibits 1-2 deficits in physical function suggests a pre-frail phenotype. The Canadian Study of Health and Aging's Clinical Frailty Scale (CFS) classifies older adult's level of frailty using a 9-level scale, ranging from "Very fit" (level 1) to "Terminally ill" (level 9). An individual is considered vulnerable or mildly frail if they fall between levels 4 and 5 on the CFS. Both assessment tools will be used to assess frailty status. It becomes more difficult to restore physical health once the individual attains 3+ deficits on the CHS or ≥ level 6 on the CFS.

The purpose of this study is to determine if the pre-frail phenotype can be reversed in participants who are pre-frail and/or vulnerable or mildly frail using CHS and CFS assessment tools respectively. Both assessment tools are used as inclusion criteria and as outcome measures within this study. To confirm frailty status, gait speed will be evaluated over a 4-meter level walkway with an addition 2-meters on either end, to allow for acceleration and deceleration of walking speed. A normal gait speed of 1-1.5 meters/second is associated with persons expressing the pre-frailty phenotype. Females are most susceptible to frailty; therefore, this investigation targets females 65 years of age and older. Eligibility criteria includes only females (65+ years) who are considered pre-frail by the CHS and vulnerable to mildly frail (levels 4-5) on the CFS, with a normal gait speed between 1-1.5 meters/second. Individuals who are considered pre-frail are highlighted for our study as we believe that this demographic is at a critical-point of physical transition between frailty phenotypes. If pre-frail individuals do not actively engage in restorative exercise to reclaim muscle strength and balance, they will remain as pre-frail or continue to regress toward the frailty phenotype.

Frailty is a multidimensional geriatric syndrome additional assessment tools will be used to determine physical strengths and deficits within each individual. Participants will be cleared for exercise participation using the Physical Activity Readiness Questionnaire - Plus (PAR-Q+) and cleared for exercise by a Certified Exercise Physiologist (CEP). The CEP in good standing with the Canadian Society for Exercise Physiology and is trained to effectively screen participants with multiple co-morbidities for exercise and prescribe appropriate exercise programs for these participants. Participants with unstable health conditions will be advised to seek physician approval before re-entering the study using the PAR-Medx assessment form. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) tool to ensure that participants are not suffering from non-observable cognitive impairment.

Participants will be randomized, using a table of random numbers, to either an Exercise (EX) or a Control (CON) group. The EX group will participate in a 16-week multi-component training intervention (3x per week, 45 to 60 minutes/session, at moderate to vigorous intensity) that will include primarily resistance exercises, an aerobic warm-up and cool down, and include both flexibility and balance exercises throughout the session (Bray et al., 2016). The CON group will be asked to maintain their normal daily living habits for the same duration (16 weeks). At the conclusion of the 16-weeks the exercise program will be made available to the CON group participants.

The sample size goal of 50 participants, 25 per group (EX=25, CON=25) was determined based-upon previous research with this population. T-tests will be used to analyze intergroup differences at baseline and post intervention. Analysis of Variance (ANOVA) will be used to analyze intragroup differences at week 0 (baseline), week 8 (mid-point) and week 17 (post intervention). Measures of intragroup differences include frailty assessment measures (CHS and CFS), the Short Physical Performance Battery (SPPB) protocol, isotonic muscle strength of the dominate arm and leg using a Biodex System 4Pro Dynamometer will be assessed and daily physical activity accumulation will be examined using the Phone FITT questionnaire.

The investigators hypothesize that those who are randomly enrolled into the exercise intervention will reverse their frailty phenotype on the CHS index (i.e. 'pre-frail' become 'non-frail') and restore physical function to lower levels (<4) on the CFS (i.e. 'vulnerable' become 'managing well'), while those in the control group will be unchanged or further regress in their frailty phenotype and become frail, or move further along the CFS toward greater levels of frailty. This research will provide support for the use of multi-component exercise as a proactive approach to restoring physical independence and quality of life for older adults.

Conditions
Fragility
Being tested
Exercise, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Also called EX group

    Participants will be randomized, using a table of random numbers, to either an Exercise (EX) or a Control (CON) group. The EX group will participate in a 16-week multi-component training intervention (3x per week, 45 to 60 minutes/session, at moderate to vigorous intensity) that will include primarily resistance exercises, an aerobic warm-up and cool down, and include both flexibility and balance exercises throughout the session (Bray et al., 2016).

  • ControlBehavioural

    Also called CON group

    The CON group will be asked to maintain their normal daily living habits for the same duration (16 weeks). At the conclusion of the 16-weeks the exercise program will be made available to the CON group.

Study groups in NCT02952443
Study groupRoleWhat they receive
ExerciseEX group will attend multi-component exercise sessions 3 times a week at 45-60 minutes a session for 16 weeks. Each session will include aerobic, flexibility, resistance and balance training but a strong emphasis will be placed on the latter two components.
Receives: Behavioral: Exercise
ControlCON group will be asked to just maintain their normal daily living habits for the duration of the study. The same exercise program will be made available to the CON group upon completion of the study.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac Healthy Study- frailty index (CHS)

    Frailty phenotype will be assessed using the Cardiac Health Study- frailty index (CHS). The CHS requires assessment of specific frailty criteria; dominate hand grip strength, a measure of self-paced normal walking speed, assessment of physical activity habits, questions about un-intentional weight loss and reporting of feelings of exhaustion. Participants are non-frail if the satisfy none of the phenotypic criteria, pre-frail if they satisfied 1 or 2 criteria and frail if the satisfied 3 or more criteria. These assessments used to determine frailty phenotype are recorded within the Short-form Physical Performance Battery (SPPB) and validated using the participant's self-selected gait speed.

    Measured: 10 min

  2. Clinical Frailty Scale (CFS)

    The level of frailty will be evaluated within each participant using the Clinical Frailty Scale (CFS). The CFS provides a simple description of each stage of physical function, from elite athlete to terminally ill. The participant is matched to the best description of their current physical function. The participant's level of physical function will be determined through the administration of the Short-form Physical Performance Battery (SPPB) and validated using the participant's self-selected gait speed.

    Measured: 5 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952443
Sponsor's protocol ID
H16-00712
Acronym
ERF
Status last verified
Nov 2016
First submitted
31 Oct 2016
Last updated
9 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bray NW, Smart RR, Jakobi JM, Jones GR. Exercise prescription to reverse frailty. Appl Physiol Nutr Metab. 2016 Oct;41(10):1112-1116. doi: 10.1139/apnm-2016-0226. Epub 2016 Sep 21.

    PubMed 27649859

Questions about this trial

What is this clinical trial studying?

An observational study of Fragility, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gareth R Jones, PhD (2508078102, gareth.jones@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Healthy Study- frailty index (CHS) (time frame: 10 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02952443, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.

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