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Strength Training
Nutrition & Strength Training for Osteoporosis (INVEST Trial)
N/A
Waitlist Available
Led By Kristen Beavers, PhD, MPH, RD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 60-85 years
BMI=30-40 kg/m^2 or BMI 27.0-<30.0 kg/m^2 plus one risk factor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months from baseline
Awards & highlights
INVEST Trial Summary
This trial will compare the effects of weight loss with and without additional interventions on indicators of bone health.
Who is the study for?
This trial is for adults aged 60-85 with a BMI between 27 and 40, who are stable in weight, can attend virtual sessions, and travel to visits. It's not for those with severe arthritis, recent major surgeries or metal implants in the hip/pelvis area, uncontrolled health conditions like hypertension or diabetes, heavy medication use including steroids or osteoporosis drugs, cognitive impairments, smokers or excessive drinkers.Check my eligibility
What is being tested?
The study compares three approaches to improve bone health and reduce fracture risk: weight loss alone (WL), WL plus wearing a weighted vest (Vest), and WL combined with resistance exercise training (RT). Participants will be assessed on how these methods affect their bones.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the vest or muscle strain from resistance exercises. The diet changes could cause digestive adjustments. However, serious side effects are unlikely as this trial focuses on lifestyle interventions rather than medications.
INVEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 60 and 85 years old.
Select...
My BMI is between 27 and 40, and I may have a risk factor if it's under 30.
Select...
My BMI is between 27 and 40, and I haven't lost more than 5% of my weight in the last 6 months.
INVEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in distal radius areal bone mineral density (aBMD)
Change in femoral neck areal bone mineral density (aBMD)
Change in femoral neck volumetric bone mineral density (vBMD)
+7 moreOther outcome measures
Cognitive Assessment
Concentration of C-terminal telopeptide (CTX) (pg/mL)
Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L)
+20 moreINVEST Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Weight Loss plus VestExperimental Treatment2 Interventions
Group II: Weight Loss Plus Resistance Exercise TrainingActive Control2 Interventions
Group III: Weight LossActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
weight loss program
2012
Completed Phase 3
~180
Vest
2020
N/A
~190
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,033 Total Patients Enrolled
1 Trials studying Osteoporosis
187 Patients Enrolled for Osteoporosis
Kristen Beavers, PhD, MPH, RDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
200 Total Patients Enrolled
Kristen Beavers, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulty following a specific diet, wearing a vest, or undergoing a CT scan due to feeling claustrophobic.I am between 60 and 85 years old.You smoke more than one cigarette per day or have smoked at least four cigarettes per week in the past year. You also consume more than 14 alcoholic drinks per week.I agree to participate, follow the study's procedures, and can get myself to visits.I have had a fracture in my spine, hip, wrist, or shoulder after turning 40, not due to a major injury or fall.You have any medical reasons that make it unsafe for you to participate in a weight loss program.My kidney or liver function is not more than twice the normal limit.I have been taking prescribed medication for my chronic back, shoulder, or knee pain for at least 3 months.I use a cane or walker and have fallen more than twice in the last year.I have osteoporosis, am on medication, and have a high fracture risk according to my test scores.I have used growth hormones, weight loss drugs, steroids, insulin, or osteoporosis meds in the last year.I have had or plan to have back surgery within a year.My BMI is between 27 and 40, and I may have a risk factor if it's under 30.I am willing to fill out study forms online and join virtual sessions.You are physically able to participate in exercise training and use the vest safely.My BMI is between 27 and 40, and I haven't lost more than 5% of my weight in the last 6 months.I haven't had severe heart, lung, brain, or blood diseases needing treatment in the last year.My kidney function is reduced, with an eGFR below 45.My blood pressure is not higher than 160/90 mmHg.I have severe arthritis and have been on prescription meds for it in the last year.You have been doing intense exercise for more than an hour a day, at least five days a week for the past six months.I am not currently participating in any other research studies, weight loss programs, or undergoing physical therapy.I am willing to fill out forms online and join virtual sessions.I have had or will have joint replacement surgery within 6 months, or I've had hip replacement surgery at any time.I have needed cancer treatment in the last year, not including non-melanoma skin cancer.I agree to participate in the study and can travel to visits on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Weight Loss plus Vest
- Group 2: Weight Loss Plus Resistance Exercise Training
- Group 3: Weight Loss
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this research project?
"Clinicaltrials.gov states this clinical trial is still in search of participants as it was initially posted on August 12th 2020 and updated most recently on November 15th 2022."
Answered by AI
What are the criteria for qualifying individuals to partake in this experiment?
"This research seeks 150 older adults ages 60-85 who are overweight or obese and have not lost more than 5% of their body weight in the past 6 months. Additionally, those interested must be willing to participate in online/electronic surveys and virtual group meetings, without any contraindications that could impede safe and effective exercise training sessions."
Answered by AI
What is the present enrollment of this trial?
"Indeed, the information on clinicaltrials.gov attests to this trial being currently open for recruitment. This experiment was first published on August 12th 2020 and was recently updated in November 15th 2022. The research is looking for 150 patients from 1 site."
Answered by AI
Are geriatric individuals accepted into this trial?
"This particular study is only accepting patients aged 60-85. By comparison, there are 19 trials for younger participants and 172 research opportunities available to those over the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Wake Forest University School of Medicine
Why did patients apply to this trial?
I am pursuing high resistance, high impact training (per the Liftmore study) before resorting to medications for my osteoporosis. I am 73 years old, active and committed to my chosen form of treatment.
PatientReceived 1 prior treatment
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