Resistance Training to Optimize Health in Pre-frail Older Adults

Study Overview
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Brief Summary
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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
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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

Official Title
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Resistance Training to Optimize Health in Pre-frail Older Adults

Conditions
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Frail Elderly

Intervention / Treatment
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* Behavioral: Higher Intensity Resistance Training
* Behavioral: Lower Intensity Resistance Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher Intensity Resistance Training<br>Participants will take part in a 12-week higher-intensity resistance training protocol. | Behavioral: Higher Intensity Resistance Training<br>* 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.<br>* Other names: HEaRT;|
| Active Comparator: Lower Intensity Resistance Training<br>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<br>* 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.<br>* Other names: LRT;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistance Training, Exercise, Walking, Safety, Feasibility Studies