Resistance Training to Optimize Health in Pre-frail Older Adults

Frail Elderly Clinical Trial

Official title:

Resistance Training to Optimize Health in Pre-frail Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593084
• Other study ID #: CAT2015-19
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: April 17, 2018
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Frailty Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events		Entire duration of the intervention (12 weeks)
Primary	Attendance rate		Entire duration of the intervention (12 weeks)
Primary	Attrition rate		Entire duration of the intervention (12 weeks)
Secondary	Timed Up and Go Test		0, 12, 20 weeks
Secondary	Short Physical Performance Battery		0, 12, 20 weeks
Secondary	Berg Balance Scale		0, 12, 20 weeks
Secondary	Activities-Specific Balance Confidence scale		0, 12, 20 weeks
Secondary	Muscle strength		0, 12, 20 weeks
Secondary	Short Form-36		0, 12, 20 weeks
Secondary	Caregiver Burden Interview Short Form		0, 12, 20 weeks
Secondary	Healthcare Utilization Questionnaires		0, 12, 20 weeks
Secondary	Peripheral Quantitative Computed Tomography analysis of muscle and bone quality		0, 12, 20 weeks
Secondary	EQ-5D-5L		0, 12, 20 weeks