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Finding the Optimal Resistance Training Intensity For Your Bones

Primary Purpose

Osteoporosis, Osteopenia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Supervised strength training (group 1)
Supervised strength training (group 2)
Home exercise
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Bone fracture, Strength training, Exercise, Bone mineral density, Muscle strength, Resistance training

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of WaterlooRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Home exercise

Supervised strength training (group 1)

Supervised strength training (group 2)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Lumbar Spine BMD
Lumbar spine (L1-L4) bone mineral density measured via DXA scan.

Secondary Outcome Measures

Fractures
Composite outcome of new non-vertebral and vertebral fractures, and progression of existing vertebral fractures. We will report the number in each category separately. We will use a fracture questionnaire for non-vertebral fractures, and vertebral fractures that come to clinical attention. Participants will undergo a DXA scan for Vertebral Fracture Assessment (VFA) at baseline and the 12-months. A vertebral fracture will be defined as having a radiographic presence of ≥25% reduction in anterior, middle, or posterior vertebral height, verified by an experienced radiologist at University Health Network via the Genant visual semi-quantitative method. Baseline VFA will be assessed for vertebral fractures and compared to VFA at 12 months to ascertain if there has been progression of new fractures; progression will be defined as progression to a new Genant level or a change in height of at least 10%.
Rate of falls per person per year
Participants will be emailed a falls calendar via a REDCap survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups.
Number of people who experience one or more falls
Participants will be emailed a falls calendar via a REDCap survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups.
Bone-free lean mass
Whole body fat- and bone-free lean mass (FBFM, kg) will be derived from DXA scans.
Appendicular lean mass
We will calculate appendicular lean mass (kg) and its index (kg/m^2) from appendicular bone-free lean mass and height (cm).
Height
Height will be a proxy measure of posture.
Occiput-to-wall distance
Occiput-to-wall distance will be a proxy measure of posture.
Knee extension peak torque
We will assess isometric knee extension peak torque using a knee extension test with a dynamometer.
30 Second Chair Stand Test.
We will use the 30 Second Chair Stand Test.
Four Square Step Test
We will use the Four Square Step Test to assess lower extremity muscle power and dynamic balance during functional tasks.
Grip Strength
We will assess grip strength of the non-dominant arm using a hand dynamometer.
10 Metre Walk Test.
We will assess gait speed using the 10 Metre Walk Test.
6 Minute Walk Test.
We will assess endurance using the 6 Minute Walk Test.
QUALEFFO-41
We will use the QUALEFFO-41 as an osteoporosis specific measure of health-related quality of life.
EQ5D5L
We will use the EQ5D5L measure as a generic health-related quality of life measure.
Serious adverse events
We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Non-serious adverse events
We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Glucose concentration
We will be taking a fasted blood sample from participants to measure plasma glucose concentrations using biochemical assay. Blood samples will only be collected from participants at the University of Waterloo site.
Insulin concentration
We will be taking a fasted blood sample from participants to measure serum insulin concentrations using radioimmunoassay. Blood samples will only be collected from participants at the University of Waterloo site.
Pro/anti-inflammatory markers (including TNFalpha, IL-6, IL-10, IL-15)
We will be taking a fasted blood sample from participants to measure plasma pro- and anti-inflammatory markers using a multiplex kit. Blood samples will only be collected from participants at the University of Waterloo site.
Oxidative stress markers/antioxidant status (including oxygen radical absorbance capacity (ORAC) assay, protein carbonyls, glutathione peroxidase activity, thyroredoxin, malondialdehyde)
We will be taking a fasted blood sample from participants to measure antioxidant status and markers of oxidative stress using commercially available assays. Blood samples will only be collected from participants at the University of Waterloo site.
Myokines
We will be taking fasting blood samples from participants to measure myokines via the Luminex Performance Assay. Blood samples will only be collected from participants at the University of Waterloo site.
Total Hip BMD
Bone mineral density of the hip measured via DXA scans
Femoral Neck BMD
Bone mineral density of the femoral neck measured via DXA scans
Trabecular Bone Score
Trabecular bone score (TBS) will be calculated using TBS iNsight software. A high TBS value indicates high quality boner structure, whereas a low TBS value demonstrates a lower quality structure. The TBS index ranges from 0.9 - 1.6.
Hip Geometry
We will use the DXA scanner's hip structural analysis feature to calculate estimates of hip geometry from proximal femur scans.
Health Service Use
We will assess direct medical resources (e.g., tests, medications, hospitalization, rehabilitation), direct non-medical resources (e.g., out of pocket expenses, transportation), indirect resources (e.g., iMTA Productivity Cost Questionnaire) and clinical events and management. We will assess resource use for incident falls, fractures or adverse events. Multiplying resources collected by jurisdictional unit costs in Canadian dollars will determine the total cost per exercise program.
Ratio of costs to QALY
We will calculate the ratio of incremental costs between the interventions, determined by trial resources, and clinical outcome (QALY) to achieve an incremental cost per life year gained outcome.
Willingness to pay
We will assess willingness to pay for various exercise models using a contingent valuation survey.
Body weight
Body weight in kg measured using scale

Full Information

First Posted
July 6, 2022
Last Updated
November 1, 2022
Sponsor
University of Waterloo
Collaborators
Canadian Institutes of Health Research (CIHR), University of Saskatchewan, University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05541432
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Canadian Institutes of Health Research (CIHR), University of Saskatchewan, University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
Bone fracture, Strength training, Exercise, Bone mineral density, Muscle strength, Resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Investigators and outcome assessors will be masked to the group allocation of participants. Participants will be masked to the hypothesis of the study.
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home exercise
Arm Type
Active Comparator
Arm Description
Home exercise program, with biweekly group virtual education and exercise classes.
Arm Title
Supervised strength training (group 1)
Arm Type
Experimental
Arm Description
In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.
Arm Title
Supervised strength training (group 2)
Arm Type
Experimental
Arm Description
In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.
Intervention Type
Other
Intervention Name(s)
Supervised strength training (group 1)
Intervention Description
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
Intervention Name(s)
Supervised strength training (group 2)
Intervention Description
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
Intervention Name(s)
Home exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lumbar Spine BMD
Description
Lumbar spine (L1-L4) bone mineral density measured via DXA scan.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Fractures
Description
Composite outcome of new non-vertebral and vertebral fractures, and progression of existing vertebral fractures. We will report the number in each category separately. We will use a fracture questionnaire for non-vertebral fractures, and vertebral fractures that come to clinical attention. Participants will undergo a DXA scan for Vertebral Fracture Assessment (VFA) at baseline and the 12-months. A vertebral fracture will be defined as having a radiographic presence of ≥25% reduction in anterior, middle, or posterior vertebral height, verified by an experienced radiologist at University Health Network via the Genant visual semi-quantitative method. Baseline VFA will be assessed for vertebral fractures and compared to VFA at 12 months to ascertain if there has been progression of new fractures; progression will be defined as progression to a new Genant level or a change in height of at least 10%.
Time Frame
Over 12 months
Title
Rate of falls per person per year
Description
Participants will be emailed a falls calendar via a REDCap survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups.
Time Frame
Over 12 months
Title
Number of people who experience one or more falls
Description
Participants will be emailed a falls calendar via a REDCap survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups.
Time Frame
Over 12 months
Title
Bone-free lean mass
Description
Whole body fat- and bone-free lean mass (FBFM, kg) will be derived from DXA scans.
Time Frame
Baseline and 12 months
Title
Appendicular lean mass
Description
We will calculate appendicular lean mass (kg) and its index (kg/m^2) from appendicular bone-free lean mass and height (cm).
Time Frame
Baseline and 12 months
Title
Height
Description
Height will be a proxy measure of posture.
Time Frame
Baseline and 12 months
Title
Occiput-to-wall distance
Description
Occiput-to-wall distance will be a proxy measure of posture.
Time Frame
Baseline and 12 months
Title
Knee extension peak torque
Description
We will assess isometric knee extension peak torque using a knee extension test with a dynamometer.
Time Frame
Baseline, 6 months, and 12 months
Title
30 Second Chair Stand Test.
Description
We will use the 30 Second Chair Stand Test.
Time Frame
Baseline, 6 months, and 12 months
Title
Four Square Step Test
Description
We will use the Four Square Step Test to assess lower extremity muscle power and dynamic balance during functional tasks.
Time Frame
Baseline, 6 months, and 12 months
Title
Grip Strength
Description
We will assess grip strength of the non-dominant arm using a hand dynamometer.
Time Frame
Baseline, 6 months, and 12 months
Title
10 Metre Walk Test.
Description
We will assess gait speed using the 10 Metre Walk Test.
Time Frame
Baseline, 6 months, and 12 months
Title
6 Minute Walk Test.
Description
We will assess endurance using the 6 Minute Walk Test.
Time Frame
Baseline, 6 months, and 12 months
Title
QUALEFFO-41
Description
We will use the QUALEFFO-41 as an osteoporosis specific measure of health-related quality of life.
Time Frame
Baseline, 6 months, and 12 months
Title
EQ5D5L
Description
We will use the EQ5D5L measure as a generic health-related quality of life measure.
Time Frame
Baseline, 6 months, and 12 months
Title
Serious adverse events
Description
We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Time Frame
Over 12 months
Title
Non-serious adverse events
Description
We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Time Frame
Over 12 months
Title
Glucose concentration
Description
We will be taking a fasted blood sample from participants to measure plasma glucose concentrations using biochemical assay. Blood samples will only be collected from participants at the University of Waterloo site.
Time Frame
Baseline and 6 months
Title
Insulin concentration
Description
We will be taking a fasted blood sample from participants to measure serum insulin concentrations using radioimmunoassay. Blood samples will only be collected from participants at the University of Waterloo site.
Time Frame
Baseline and 6 months
Title
Pro/anti-inflammatory markers (including TNFalpha, IL-6, IL-10, IL-15)
Description
We will be taking a fasted blood sample from participants to measure plasma pro- and anti-inflammatory markers using a multiplex kit. Blood samples will only be collected from participants at the University of Waterloo site.
Time Frame
Baseline and 6 months
Title
Oxidative stress markers/antioxidant status (including oxygen radical absorbance capacity (ORAC) assay, protein carbonyls, glutathione peroxidase activity, thyroredoxin, malondialdehyde)
Description
We will be taking a fasted blood sample from participants to measure antioxidant status and markers of oxidative stress using commercially available assays. Blood samples will only be collected from participants at the University of Waterloo site.
Time Frame
Baseline and 6 months
Title
Myokines
Description
We will be taking fasting blood samples from participants to measure myokines via the Luminex Performance Assay. Blood samples will only be collected from participants at the University of Waterloo site.
Time Frame
Baseline and 6 months
Title
Total Hip BMD
Description
Bone mineral density of the hip measured via DXA scans
Time Frame
Baseline and 12 months
Title
Femoral Neck BMD
Description
Bone mineral density of the femoral neck measured via DXA scans
Time Frame
Baseline and 12 months
Title
Trabecular Bone Score
Description
Trabecular bone score (TBS) will be calculated using TBS iNsight software. A high TBS value indicates high quality boner structure, whereas a low TBS value demonstrates a lower quality structure. The TBS index ranges from 0.9 - 1.6.
Time Frame
Baseline and 12 months
Title
Hip Geometry
Description
We will use the DXA scanner's hip structural analysis feature to calculate estimates of hip geometry from proximal femur scans.
Time Frame
Baseline and 12 months
Title
Health Service Use
Description
We will assess direct medical resources (e.g., tests, medications, hospitalization, rehabilitation), direct non-medical resources (e.g., out of pocket expenses, transportation), indirect resources (e.g., iMTA Productivity Cost Questionnaire) and clinical events and management. We will assess resource use for incident falls, fractures or adverse events. Multiplying resources collected by jurisdictional unit costs in Canadian dollars will determine the total cost per exercise program.
Time Frame
Baseline, 6 months, and 12 months
Title
Ratio of costs to QALY
Description
We will calculate the ratio of incremental costs between the interventions, determined by trial resources, and clinical outcome (QALY) to achieve an incremental cost per life year gained outcome.
Time Frame
Baseline, 6 months, and 12 months
Title
Willingness to pay
Description
We will assess willingness to pay for various exercise models using a contingent valuation survey.
Time Frame
Baseline, 6 months, and 12 months
Title
Body weight
Description
Body weight in kg measured using scale
Time Frame
Baseline, 6 months and 12 months
Other Pre-specified Outcome Measures:
Title
Dietary Intake
Description
We will use ASA24 to collect information on the participant's dietary intake through the self-administered 24-hour dietary record. Participants will report all food and beverage items and quantities on 3 days (2 weekday, 1 weekend day) at baseline, 6 months, and 12 months. We will also use the SCREEN2 tool at baseline only. We will report descriptive data on energy, protein, calcium, and vitamin D intake, and perform exploratory analyses of changes in these outcomes over time. We will perform subgroup analyses: 1) Baseline daily calcium (<1000 vs. >1000 mg per day); and 2) Baseline protein intake (<1.2g/kg body weight per day). We will explore changes in participants who are referred to a dietitian for counselling because of low intakes of protein, calcium, or vitamin D.
Time Frame
Baseline, 6 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kylie Sullivan, MSc
Phone
519-904-0660
Ext
4222
Email
krsullivan@uwaterloo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora Giangregorio, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kylie Sullivan, MSc.
Phone
(519)- 904-0660
Ext
4222
Email
krsullivan@uwaterloo.ca

12. IPD Sharing Statement

Plan to Share IPD
No
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11069188
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Citation
Costa AG, Wyman A, Siris ES, Watts NB, Silverman S, Saag KG, Roux C, Rossini M, Pfeilschifter J, Nieves JW, Netelenbos JC, March L, LaCroix AZ, Hooven FH, Greenspan SL, Gehlbach SH, Diez-Perez A, Cooper C, Compston JE, Chapurlat RD, Boonen S, Anderson FA Jr, Adachi JD, Adami S. When, where and how osteoporosis-associated fractures occur: an analysis from the Global Longitudinal Study of Osteoporosis in Women (GLOW). PLoS One. 2013 Dec 11;8(12):e83306. doi: 10.1371/journal.pone.0083306. eCollection 2013.
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Finding the Optimal Resistance Training Intensity For Your Bones

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