NCT02593084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 18, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

October 27, 2015

Last Update Submit

April 17, 2018

Conditions

Frail Elderly

Keywords

Resistance TrainingExerciseWalkingSafetyFeasibility Studies

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Higher Intensity Resistance Training

EXPERIMENTAL

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

Behavioral: Higher Intensity Resistance Training

Lower Intensity Resistance Training

ACTIVE COMPARATOR

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

Higher Intensity Resistance TrainingBEHAVIORAL

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
Higher Intensity Resistance Training
Lower Intensity Resistance TrainingBEHAVIORAL

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
Lower Intensity Resistance Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ada Tang, PT PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 30, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)