Clinical trial NCT02593084: Resistance Training to Optimize Health in Pre-frail Older Adults
Official title: Resistance Training to Optimize Health in Pre-frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Resistance Training
Exercise
Walking
Safety
Feasibility Studies
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Frailty Network
First posted: 2015-10-30
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: Entire duration of the intervention (12 weeks)
measure: Attendance rate
timeFrame: Entire duration of the intervention (12 weeks)
measure: Attrition rate
timeFrame: Entire duration of the intervention (12 weeks)
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: 0, 12, 20 weeks
measure: Short Physical Performance Battery
timeFrame: 0, 12, 20 weeks
measure: Berg Balance Scale
timeFrame: 0, 12, 20 weeks
measure: Activities-Specific Balance Confidence scale
timeFrame: 0, 12, 20 weeks
measure: Muscle strength
timeFrame: 0, 12, 20 weeks
measure: Short Form-36
timeFrame: 0, 12, 20 weeks
measure: Caregiver Burden Interview Short Form
timeFrame: 0, 12, 20 weeks
measure: Healthcare Utilization Questionnaires
timeFrame: 0, 12, 20 weeks
measure: Peripheral Quantitative Computed Tomography analysis of muscle and bone quality
timeFrame: 0, 12, 20 weeks
measure: EQ-5D-5L
timeFrame: 0, 12, 20 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ada Tang, PT PhD
role: PRINCIPAL_INVESTIGATOR
References: