Recruiting

Exercise Intervention

Sponsor:

University of British Columbia

Code:

NCT02952443

Conditions

Fragility

Eligibility Criteria

Sex: Female

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise

Control

Study Details

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

Study ID

NCT02952443

Start date

Nov, 2016

Status verified date

Nov, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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+
  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Exercise

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).

Control

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.

Primary outcome measure

  • Cardiac Healthy Study- frailty index (CHS) [ Time Frame: 10 min ]
  • Clinical Frailty Scale (CFS) [ Time Frame: 5 min ]

Central Contacts and Locations

Central contacts

Gareth R Jones, PhD

2508078102gareth.jones@ubc.ca

Locations

Healthy Exercise and Aging Lab - UBC Okanagan

Recruiting

Kelwona, British Columbia, Canada, V1V 1V7

Contacts

Gareth R Jones, PhD

2508078102gareth.jones@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Nov 9, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-11-09.