Bone Response to Exercise in Women on Antiresorptive Medications (BRRIE)
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|ClinicalTrials.gov Identifier: NCT04275011|
Recruitment Status : Suspended (The study has been suspended until further notice due to COVID-19.)
First Posted : February 19, 2020
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Bone Loss||Other: Progressive Resistance and Impact Exercise Other: Static Balance and Postural Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a single-blinded RCT comparing moderate-high progressive resistance training and impact exercise to an attention control who will be performing static posture and balance exercises.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Using a computer-generated random selection process, participants will be randomized in a 1:1 allocation ratio in blocks which will be randomly determined. Allocation will be concealed from all but the person performing the randomization, the participants, and the exercise trainers. Although the participants cannot be blinded to the assigned exercise group, they will simply be informed that the purpose of the study is to compare two different exercise programs with no indication regarding the study hypothesis. Research staff blinded to group allocation will have access to the assessment forms. An alternate research staff member will collect or enter data that may cause unblinding (e.g., randomization, exercise adherence logs). Exercise trainers who are unblinded to group allocation will have access to the exercise training manual. Completed outcome assessments and exercise training data will be stored in separate password protected files to avoid exposing group allocation.|
|Official Title:||Bone Response to Resistance and Impact Exercise (BRRIE) in Women on Antiresorptive Medications: A Randomized Controlled Trial|
|Actual Study Start Date :||January 2, 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||November 2020|
Active Comparator: Static Posture and Balance Exercise
Participants in the control group will receive equal attention through a static posture and balance exercise class two times per week, in a small group setting.
Other: Static Balance and Postural Exercise
Participants in the attention control group will perform static posture and balance exercises (e.g., low intensity yoga poses) and will be given the same attention as the participants in the intervention group. The small group exercises will be performed twice a week, 30-45 minutes per session, over 6 months, with at least one day of rest between each session. The exercise program will be supervised by a certified personal trainer and yoga instructor who is BoneFit trained.
Experimental: Progressive Resistance and Impact Exercise
The exercise program will include two progressive resistance and impact exercise training sessions per week in a small group setting. Exercises will be individually tailored to the participants' abilities and designed to achieve a maximum 80-85% 1RM.
Other: Progressive Resistance and Impact Exercise
Full body resistance and impact exercises will be performed twice a week for 30-45 minutes over a 6 month period. There will be at least one day of rest between scheduled exercise sessions. Participants will be individually prescribed variations of push, pull, squat, lift and carry movements targeting major muscle groups that they can safely complete, and accessory exercises to help develop movement patterns. Exercises will challenge both the upper and lower body using functional movement patterns. Each muscle group will be trained twice a week. During the first month, participants will focus on completing exercises with good form at a low intensity. Once form is mastered, exercises will be progressed (by increasing load, or challenge of the movement) to a moderate to high exercise intensity (80-85% 1RM) so that the participant can complete a maximum of 8 (~80% 1RM) or 6 (~85% 1RM) repetitions with 1-2 repetitions in reserve for 3 sets at a rating of perceived exertion (RPE) of 8-9.
- Change from baseline Serum Sclerostin at 3 months and 6 months. [ Time Frame: Baseline, 3-month and 6-month follow up. ]The primary outcome measure will be serum sclerostin. Venous blood samples will be taken by experienced phlebotomists between 8:00 and 10:00 am, after an overnight fast (8-12 hours). Participants will also be instructed to refrain from exercise for 48 hours prior to blood collection. An assessor who is blind to group allocation will measure sclerostin using ab221836 Human SOST SimpleStep ELISA® (Enzyme-Linked Immunosorbent Assay) supplied by Abcam (Abcam Inc., Toronto, Ontario, Canada).
- Descriptive Data - Demographic information [ Time Frame: Baseline ]We will collect data such as demographic information including date of birth, race, formal education and marital status.
- Descriptive Data - Medical History [ Time Frame: Baseline ]Current and past medical history (including family history) will be collected including recent/past drug therapies and bone-related medications, reproductive history (e.g. age at menarche or menopause), past surgical history, falls risk (e.g. number of falls within the last 12 months) and fracture history, as well as current alcohol consumption and smoking status.
- Descriptive Data - Physical Activity [ Time Frame: Baseline ]Baseline physical activity will be assessed using a Bone-specific Physical activity Questionnaire (BPAQ), and by asking participants to wear accelerometers for one week prior to participating in the exercise program.
- Descriptive Data - Dietary Intake [ Time Frame: Baseline, 3-months, and 6-months ]To assess dietary energy, calcium and protein intake, participants will be asked to complete an Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool (Canada Version).
- Other bone biomarkers - Serum P1NP [ Time Frame: Baseline, 3-month and 6-month follow up. ]Serum P1NP will be be measured by the same single blinded assessor. P1NP will be measured using Human Total Procollagen Type I Intact N-Terminal Propeptide (TP1NP) ELISA Kit supplied by MyBioSource (MyBioSource Inc., San Diego, California, USA).
- Other bone biomarkers - CTX [ Time Frame: Baseline, 3-month and 6-month follow up. ]CTX will be measured in the blood by the same single blinded assessor. Beta-crosslaps CTX will be measured using Human beta-crosslaps (bCTx) ELISA Kit supplied by Cusabio (Cusabio Technology LLC, Houston, Texas, USA).
- Other bone biomarkers - Parathyroid Hormone [ Time Frame: Baseline, 3-month and 6-month follow up. ]PTH will be measured in the blood by the same single blinded assessor. Parathyroid hormone will be measured using ab230931 Human PTH SimpleStep ELISA® Kit supplied by Abcam (Abcam Inc., Toronto, Ontario, Canada).
- Other bone biomarkers - Vitamin D [ Time Frame: Baseline, 3-month and 6-month follow up. ]Vitamin D will be measured in the blood by the same single blinded assessor. Vitamin D will be measured using Human 25-Hydroxyvitamin D-1 Aplha Hydroxylase Mitochondrial (CYPB27B1) ELISA® Kit supplied by Cusabio (Cusabio Technology LLC, Houston, Texas, USA).
- Other bone biomarkers - Calcium [ Time Frame: Baseline, 3-month and 6-month follow up. ]Calcium will be measured in the blood by the same single blinded assessor. Calcium will be measured using ab112115 Calcium Quantification Kit - Red Fluorescence supplied by Abcam (Abcam Inc., Toronto, Ontario, Canada).
- Physical function and mobility - 40 metre Fast-paced Walk [ Time Frame: Baseline, 3-month and 6-month follow up. ]Physical function and mobility will be assessed using the 40 m fast-paced walk test. Time to complete test will be recorded.
- Physical function and mobility - 30-second Sit-to-Stand Test [ Time Frame: Baseline, 3-month and 6-month follow up. ]Physical function and mobility will be assessed using the 30-second sit-to-stand test. Number of sit-to-stand repetitions performed in 30 seconds will be recorded.
- Physical function and mobility - 4-square Step Test [ Time Frame: Baseline, 3-month and 6-month follow up. ]Physical function and mobility will be assessed using the 4-square step test. Time to complete test will be recorded.
- Physical function and mobility - Stair Climb Test [ Time Frame: Baseline, 3-month and 6-month follow up. ]Physical function and mobility will be assessed using the stair climb test. Time to complete test will be recorded.
- Quality of Life - EQ-5D [ Time Frame: Baseline, 3-month and 6-month follow up. ]The 5 level EuroQol EQ-5D instrument (EQ-5D-5L) will be used to assess the quality of life of the participants. The EQ-5D-5L instrument includes a descriptive system that is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are coded from 11111 (no problems in all dimensions) to 55555 (extreme problems in all dimensions). A lower score is better. There is also a visual analogue scale that is used to measure the individuals self-rated overall health on a particular day. The visual analogue scale is scored from 0 (worst health imaginable) to 100 (best health imaginable).
- Quality of Life - QUALEFFO-41 [ Time Frame: Baseline, 3-month and 6-month follow up. ]The Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) questionnaire will be used to assess quality of life of the participants. The QUALEFFO-41 questionnaire is specific to people with osteoporosis and includes the following domains: pain, activities of daily living, mobility, leisure and social activity, general health perception, and mental function. Scores range from 0-100, lower is better.
- Bone Mineral Density [ Time Frame: Baseline and 6 months. ]Certified technologists, blind to group allocation, will assess bone mineral density (g/cm2) at the spine (L1-L4) and femoral neck using a dual energy X-ray absorptiometry (DXA) scan (Hologic Inc, Bedford, MA).
- Body Composition [ Time Frame: Baseline and 6 months. ]Certified technologists, blind to group allocation, will assess body mass (kg) and use this to determine whole body fat- and bone-free lean mass (FBFM, in kg) and appendicular lean mass (ALM, in kg) and its index (ALMI) using a dual energy X-ray absorptiometry (DXA) scan (Hologic Inc, Bedford, MA).
- Feasibility (Number of participants retained) [ Time Frame: 6 months. ]Feasibility outcomes will include a record of the number of participants recruited and retained, and the acceptability of the attention control group (e.g., low dropout rate after randomization).
- Feasibility (Adherence) [ Time Frame: Through study, 6 months. ]The exercise trainers will be provided with an attendance sheet at every exercise session to monitor the number of exercise sessions participants attend to determine adherence.
- Feasibility (Acceptability) [ Time Frame: 6 months. ]We will conduct one exit interview to determine the participants' perspective on the intervention and control groups, and if they understood the purpose of the study.
- Falls [ Time Frame: Through study, up to 6 months ]Falls will be recorded using a prospective notification system to assess the number of falls, the number of fallers/non-fallers/frequent fallers and the fall rate. Participants will be asked weekly to report any falls that occurred outside of, and during, the exercise training program. Participants will be instructed to provide their weekly assessments to the exercise trainers when they attend their scheduled exercise sessions. Exercise trainers will check to ensure completion, confirm the date, injuries and hospitalization after a fall has been reported, and will follow-up with participants who have missing assessments.
- Fractures [ Time Frame: Through study, up to 6 months ]Participants will also be asked to report any new fractures or injuries, related or unrelated to the exercise training. Exercise trainers will complete an adverse event report to ascertain the cause and timing of any injuries. To verify fracture details, written consent will be obtained to abstract data from medical records.
- Adverse Events [ Time Frame: Through study, up to 6 months. ]According to Health Canada a serious adverse event is defined as ". . . an event (experience) or reaction is any untoward medical occurrence that at any dose (a) results in death, (b) is life-threatening, (c) requires inpatient hospitalization or prolongation of existing hospitalization, (d) results in persistent or significant disability/ incapacity, or (e) is a congenital anomaly/birth defect". Whereas a non-serious adverse event includes bone/limb pain, myalgia or muscle cramps (e.g. pain, cramps or aches), and injuries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275011
|University of Waterloo|
|Waterloo, Ontario, Canada, N2L 3G1|
|Principal Investigator:||Lora M Giangregorio, PhD||University of Waterloo, Schlegel-UW Research Institute for Aging|