Clinical trial NCT05541432: Finding the Optimal Resistance Training Intensity For Your Bones
Official title: Finding the Optimal Resistance Training Intensity For Your Bones: A Randomized Controlled Trial (FORTIFY Bones)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoporosis
Osteopenia
Keywords: Bone fracture
Strength training
Exercise
Bone mineral density
Muscle strength
Resistance training
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Saskatchewan
name: University Health Network, Toronto
First posted: 2022-09-15
Enrollment: 324
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1:1 ratio to one of three arms. Participants will perform exercise or control activities twice weekly for 12 months. Not all participants will start and end at the same time.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lumbar Spine bone mineral density (BMD)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Fractures
timeFrame: Over 12 months
measure: Rate of falls per person per year
timeFrame: Over 12 months
measure: Number of people who experience one or more falls
timeFrame: Over 12 months
measure: Bone-free lean mass
timeFrame: Baseline and 12 months
measure: Appendicular lean mass
timeFrame: Baseline and 12 months
measure: Height
timeFrame: Baseline and 12 months
measure: Occiput-to-wall distance
timeFrame: Baseline and 12 months
measure: Knee extension peak torque
timeFrame: Baseline, 6 months, and 12 months
measure: 30 Second Chair Stand Test.
timeFrame: Baseline, 6 months, and 12 months
measure: Four Square Step Test
timeFrame: Baseline, 6 months, and 12 months
measure: Grip Strength
timeFrame: Baseline, 6 months, and 12 months
measure: 10 Metre Walk Test.
timeFrame: Baseline, 6 months, and 12 months
measure: 6 Minute Walk Test.
timeFrame: Baseline, 6 months, and 12 months
measure: Osteoporosis-specific quality of life (QUALEFFO-41)
timeFrame: Baseline, 6 months, and 12 months
measure: Quality of life (EQ5D5L)
timeFrame: Baseline, 6 months, and 12 months
measure: Serious adverse events
timeFrame: Over 12 months
measure: Non-serious adverse events
timeFrame: Over 12 months
measure: Glucose concentration
timeFrame: Baseline and 6 months
measure: Insulin concentration
timeFrame: Baseline and 6 months
measure: Pro/anti-inflammatory markers
timeFrame: Baseline and 6 months
measure: Oxidative stress markers/antioxidant status (including oxygen radical absorbance capacity (ORAC) assay, protein carbonyls, glutathione peroxidase activity, thioredoxin, malondialdehyde)
timeFrame: Baseline and 6 months
measure: peptides synthesized and released by myocytes in muscle tissue
timeFrame: Baseline and 6 months
measure: Total Hip BMD
timeFrame: Baseline and 12 months
measure: Femoral Neck BMD
timeFrame: Baseline and 12 months
measure: Trabecular Bone Score
timeFrame: Baseline and 12 months
measure: Hip Geometry
timeFrame: Baseline and 12 months
measure: Health Service Use
timeFrame: Baseline, 6 months, and 12 months
measure: Ratio of costs to QALY
timeFrame: Baseline, 6 months, and 12 months
measure: Willingness to pay
timeFrame: Baseline, 6 months, and 12 months
measure: Body weight
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
measure: Dietary Intake
timeFrame: Baseline, 6 months, and 12 months
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
city: Markham
country: Canada
facility: University of Toronto
city: Saskatoon
country: Canada
facility: University of Saskatchewan
Study officials:
affiliation: University of Waterloo
name: Lora Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
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