Resistance Training to Optimize Health in Pre-frail Older Adults

April 17, 2018 updated by: McMaster University
Exercise programs, particularly resistance training programs using weights or resistance bands, can help improve or maintain mobility and function in older adults, preserve independent living, and improve quality of life. This study will examine the safety and feasibility of a novel, higher intensity resistance training program in older adults, and compare the effects with standard care, lower intensity training. It is anticipated that both programs will be safe and feasible, but higher-intensity training will lead to greater improvements in quality of life, mobility and strength, which are part of the physical phenotype definition of frailty and markers of mobility disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is critically important to identify effective strategies to reduce the risk and impact of mobility disability and frailty in older adults. Exercise, particularly resistance training (RT), has the potential to influence a person's ability to navigate around their environment and impact the components of the frailty phenotype which include weakness, physical inactivity, and slowness. Higher training intensities have been used with athletes and younger adults to achieve greater gains in strength, but the feasibility and effectiveness is less established in older persons who exhibit preclinical disability, or are at-risk for mobility decline where conservative protocols are typically employed. Higher intensity RT may be an innovative and effective strategy in preclinical disability pre-frailty to reduce the risk and impact of future frailty and mobility decline.

This study aims to examine: 1) the safety and feasibility of a 12-week higher intensity RT protocol in community dwelling older adults at risk for mobility disability, and 2) the effects of this protocol on walking, balance, muscle strength, quality of life compared to lower intensity RT

It is hypothesized that the higher intensity RT: 1) is safe and feasible for at-risk community-dwelling older adults, 2) more effective in improving walking, balance, muscle strength, and quality of life than lower intensity RT

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1C7
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • self-reported mobility limitations
  • living in the community
  • not currently engaged in regular resistance training
  • able to follow instructions

Exclusion Criteria:

  • contraindications for intensive resistance training (e.g. recent cardiovascular event, fracture within the past 12 months)
  • musculoskeletal injuries for which intervention participants are receiving concomitant rehabilitation treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Higher Intensity Resistance Training
Participants will take part in a 12-week higher-intensity resistance training protocol.
Behavioral: Higher Intensity Resistance Training
Bi-weekly resistance training for 12 weeks using multi-joint movements involving both upper and lower extremities (e.g squats). Participants will perform 3-5 sets of 3-6 repetitions at Rating of Perceived Exertion 8/10. The intervention will be administered by a Physical Therapist or trained fitness professional.
Other Names:
  • HEaRT
Active Comparator: Lower Intensity Resistance Training
Participants will take part in a 12-week lower-intensity resistance training protocol that will serve as the active comparator.
Behavioral: Lower Intensity Resistance Training
Bi-weekly resistance training for 12 weeks using single-joint movements involving both upper and lower extremities (e.g leg extension). Participants will perform 3-5 sets of 8-10 repetitions at Rating of Perceived Exertion 5/10. The intervention will be administered by a Physical Therapist or trained fitness professional.
Other Names:
  • LRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: Entire duration of the intervention (12 weeks)
Entire duration of the intervention (12 weeks)
Attendance rate
Time Frame: Entire duration of the intervention (12 weeks)
Entire duration of the intervention (12 weeks)
Attrition rate
Time Frame: Entire duration of the intervention (12 weeks)
Entire duration of the intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Timed Up and Go Test
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Short Physical Performance Battery
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Berg Balance Scale
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Activities-Specific Balance Confidence scale
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Muscle strength
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Short Form-36
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Caregiver Burden Interview Short Form
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Healthcare Utilization Questionnaires
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
Peripheral Quantitative Computed Tomography analysis of muscle and bone quality
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks
EQ-5D-5L
Time Frame: 0, 12, 20 weeks
0, 12, 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Frailty Network

Investigators

  • Principal Investigator: Ada Tang, PT PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAT2015-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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