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Rehabilitation for Disuse Atrophy (MAC Trial)
MAC Trial Summary
This trial will have two phases. In the first phase, participants will have one leg immobilized for seven days to simulate disuse. In the second phase, participants will do 14 days of bilateral leg rehabilitation. The investigators will study the effects of disuse and rehabilitation on the participants' skeletal muscles.
MAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMAC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MAC Trial Design
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Who is running the clinical trial?
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- People of all races and ethnicities are welcome to participate.I have a lung condition.You have a high body mass index (BMI) or excess body fat that makes it difficult to collect a muscle biopsy.I have had recent problems with balance or falls.I am a woman who has not gone through menopause.I am between 50 and 65 years old.I have diabetes or another untreated hormone-related or metabolic condition.You have a condition called sarcopenia, which means you have loss of muscle mass and strength typically seen in older people.I have an ongoing infection or a recent acute infection.I do not have serious heart disease.I can meet the study's travel needs.I have a history of stroke or blood clotting disorders.You have been following a strict diet for weight loss or weight gain in the past 6 months.I have had a blood clot in my lungs or elsewhere in my body.I haven't used steroids, growth hormones, or immunosuppressants in the last year.Your weight has changed by 5% or more in the last 6 months.I am currently on hormone replacement therapy.I have been treated for a cancer other than basal cell carcinoma in the last 3 years.I have experienced leg pain from walking.I have had a gastrointestinal bleed in the last year.My kidney function is impaired with creatinine levels above 1.5 mg/dl.My job requires me to stand for more than an hour without a break.You have a body mass index (BMI) less than 20 or have had problems with eating within the past year.You have a history of alcohol or drug abuse.I cannot safely use crutches due to my musculoskeletal condition.I have a condition affecting the blood vessels outside my heart and brain.
- Group 1: Female Rehabilitation (F-REHAB)
- Group 2: Female Control (F-CON)
- Group 3: Male Rehabilitation (M-REHAB)
- Group 4: Male Control (M-CON)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this clinical trial encompass participants outside of the senior age demographic?
"This trial has established a 50-year age floor and 65 year ceiling for eligibility."
What is the objective of this experiment?
"The primary aim of this scientific exploration, that will be assessed on the 21st day after 7 sessions of rehabilitation, is to use Quantitative RNA-sequencing. Supplementary objectives include an assessment of Muscle fiber type through biopsied samples and collecting dietary information with a multi-pass 24hr survey tool. Additionally, accelerometers placed around the waist and ankle are used to measure physical activity levels."
What is the enrollment capacity for this research project?
"Affirmative. According to the clinicaltrials.gov database, recruitment for this trial is still active. It was first posted on August 27th 2021 and its latest update occurred March 31st 2022; 80 volunteers are needed from a single research site."
Am I eligible for participation in this medical trial?
"For this trial, researchers are seeking 80 individuals aged 50-65 who have already begun rehabilitation. Further criteria include: gender neutrality, all races and ethnic backgrounds, and general health (as specified)."
Is recruitment for this experiment still ongoing?
"Affirmative. As per the information on clinicaltrials.gov, this research effort is actively recruiting participants as of March 2021. It was initially published in August 2021 and seeks 80 individuals from a single medical centre."
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