Exercise Intervention to Reverse Frailty

NCT02952443 | Unknown

• 1 other identifier: H16-00712
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fragility

Outcome Measures

Primary Outcomes (2)

• 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.

  10 min

• 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.

  5 min

Other Outcomes (2)

• Biodex Pro4 Dynamometer: Assessment of Isotonic strength in the upper and lower body.

  20 min

• Short-Physical Performance Battery (SPPB)

  10 min

Study Arms (2)

Exercise

EX 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.

Behavioral: Exercise

Control

CON 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.

Behavioral: Control

Interventions

Exercise BEHAVIORAL

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).

Also known as: EX group

Exercise

Control BEHAVIORAL

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.

Also known as: CON group

Control

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Female
• 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+
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Healthy Exercise and Aging Lab - UBC Okanagan

Kelwona, British Columbia, V1V 1V7, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 27649859 BACKGROUND

Related Links

• Video

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gareth R Jones, PhD

  UBC Okanagan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gareth R Jones, PhD

CONTACT

2508078102; gareth.jones@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 9, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)