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Completed

NCT Number: NCT02593084

Resistance Training to Optimize Health in Pre-frail Older Adults

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher Intensity Resistance Training

Behavioral

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

Lower Intensity Resistance Training

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Frailty Network

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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