Finding the Optimal Resistance Training Intensity For Your Bones

NCT ID: NCT05541432

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2026-09-30

Brief Summary

Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Further, individuals with osteoporosis are often told to avoid lifting or moving in certain ways, which creates fear and activity avoidance. Conversely, research suggests that to stimulate bone, you need higher loads on bone, with either higher intensity resistance training or impact exercise - the types of things people with low bone mass are told to avoid. Our study will examine different types of exercise intensity and how they translate to building bone in people with low bone mineral density (BMD).

Detailed Description

The FORTIFY Bones study will compare the effect of supervised twice-weekly progressive resistance training (PRT) at moderate or high intensity for one year to a home posture and balance exercise program on lumbar spine bone mineral density (BMD), in individuals with low bone mass not taking osteoporosis medication. As secondary analyses, we will examine the differences between each resistance training intensity and home exercise, and between resistance training intensities on all outcomes. Participants will be randomized to one of three exercise programs to be completed twice weekly: posture and balance exercise program at home, in-person, supervised progressive resistance training at 70% of estimated 1 Repetition Maximum (1RM) intensity, or in-person, supervised progressive resistance training at an 85% estimated 1RM intensity. The study is a multi-centre trial that will take place at the University of Waterloo, Toronto General Hospital, and the University of Saskatchewan. The long-term goal of this study is to generate evidence to support decision-making on the type of exercises for people with osteoporosis.

Conditions

Osteoporosis; Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Home exercise

Home exercise program, with biweekly group virtual education and exercise classes.

Group Type: ACTIVE_COMPARATOR

Home exercise

Intervention Type: OTHER

Participants in this arm will complete twice-weekly upper and lower body exercises at home, focused on posture and balance. Participants will meet 1:1 with an exercise physiologist who will select and prescribe exercises. Participants will also be invited to attend twice monthly virtual exercise and education sessions.

Supervised strength training (group 1)

In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.

Group Type: EXPERIMENTAL

Supervised strength training (group 1)

Intervention Type: OTHER

Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of 10-12 repetitions at an intensity of \~70% of estimated 1 repetition maximum.

Supervised strength training (group 2)

In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.

Group Type: EXPERIMENTAL

Supervised strength training (group 2)

Intervention Type: OTHER

Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of \~4-6 repetitions at an intensity of 85% of estimated one repetition maximum, with a warm-up set of 8 repetitions at their estimated 70% estimated one repetition maximum to attempt to match the volume performed in the other resistance training group.

Interventions

Supervised strength training (group 1)

Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of 10-12 repetitions at an intensity of \~70% of estimated 1 repetition maximum.

Intervention Type: OTHER

Supervised strength training (group 2)

Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of \~4-6 repetitions at an intensity of 85% of estimated one repetition maximum, with a warm-up set of 8 repetitions at their estimated 70% estimated one repetition maximum to attempt to match the volume performed in the other resistance training group.

Intervention Type: OTHER

Home exercise

Participants in this arm will complete twice-weekly upper and lower body exercises at home, focused on posture and balance. Participants will meet 1:1 with an exercise physiologist who will select and prescribe exercises. Participants will also be invited to attend twice monthly virtual exercise and education sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 50 or over
• Has received 2 vaccines for COVID-19
• Has femoral neck, total hip, or lumbar spine BMD T-score of ≤ -1, OR has been or have a FRAX probability of fracture of greater than or equal to 20% for major osteoporotic fracture or 3% or greater for hip fracture.*

• Individuals at high risk of fracture (i.e., risk in next 10 years is >20% according to FRAX) should be offered medication for osteoporosis. We will only include individuals at high risk of fracture who have declined medication or who had been on osteoporosis medication and decided to cease taking it in the appropriate timeline (as outlined by PI's and Physician).
• Willing to participate in 2x weekly exercise sessions
• Self-reported as postmenopausal for ≥ 2 years, OR postmenopausal stats confirmed via blood test (female participants only)

Exclusion Criteria

• Is unable to communicate in English
• Has conditions affecting bone health
• Takes or has taken medications affecting bone in the last 12 months or longer (as determined by the research team)
• Has had a clinical or symptomatic spine fracture in the last 12 months, or a lower/upper limb fracture in the last 6 months
• Has had a joint replacement in the last 6 months
• Is receiving palliative care
• Has major surgery planned in the next 12 months
• Has had cancer within the last 2 years (excluding non-melanoma skin cancer)
• Has planned travel time of greater than 6 weeks
• Has been diagnosed with dementia
• Is already participating in moderate- or high-intensity progressive resistance training ≥ twice weekly
• Weighs over 450 lbs
• Has contraindications to resistance training

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lora Giangregorio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

University of Waterloo

Waterloo, Ontario, Canada

University of Toronto

Markham, , Canada

University of Saskatchewan

Saskatoon, , Canada

Countries

Canada

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Other Identifiers

41337

Identifier Type: -

Identifier Source: org_study_id