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CompletedNCT02593084Updated Apr 18, 2018

Resistance Training to Optimize Health in Pre-frail Older Adults

An interventional study of Higher Intensity Resistance Training and Lower Intensity Resistance Training in Frail Elderly, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by McMaster University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Frail Elderly

Keywords

  • Resistance Training
  • Exercise
  • Walking
  • Safety
  • Feasibility Studies
03

In context

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Higher Intensity Resistance Training

    Participants will take part in a 12-week higher-intensity resistance training protocol.

    Behavioral: Higher Intensity Resistance Training

  • 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

Interventions

  • BehavioralHigher 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.

    Also known as: HEaRT

  • BehavioralLower 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.

    Also known as: LRT

06

What researchers measure

Primary outcomes

  1. Occurrence of adverse events

    Time frame: Entire duration of the intervention (12 weeks)

  2. Attendance rate

    Time frame: Entire duration of the intervention (12 weeks)

  3. Attrition rate

    Time frame: Entire duration of the intervention (12 weeks)

Secondary outcomes

  1. Timed Up and Go Test

    Time frame: 0, 12, 20 weeks

  2. Short Physical Performance Battery

    Time frame: 0, 12, 20 weeks

  3. Berg Balance Scale

    Time frame: 0, 12, 20 weeks

  4. Activities-Specific Balance Confidence scale

    Time frame: 0, 12, 20 weeks

  5. Muscle strength

    Time frame: 0, 12, 20 weeks

  6. Short Form-36

    Time frame: 0, 12, 20 weeks

  7. Caregiver Burden Interview Short Form

    Time frame: 0, 12, 20 weeks

  8. Healthcare Utilization Questionnaires

    Time frame: 0, 12, 20 weeks

  9. Peripheral Quantitative Computed Tomography analysis of muscle and bone quality

    Time frame: 0, 12, 20 weeks

  10. EQ-5D-5L

    Time frame: 0, 12, 20 weeks

07

Study locations

1 site
  • McMaster University
    Hamilton, Ontario L8S 1C7, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02593084
Lead sponsor
McMaster University
Collaborators
Canadian Frailty Network
Responsible party
Sponsor
First posted
Oct 30, 2015
Start date
Jan 2016
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Apr 18, 2018

Study contacts

Ada Tang, PT PhD
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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