Trial Summary
What is the purpose of this trial?This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance in postmenopausal women.
Is the treatment PrO2 Fit (IMT Trainer) a promising treatment for postmenopausal women?Yes, PrO2 Fit (IMT Trainer) is a promising treatment for postmenopausal women. It can help improve muscle strength and body composition, which are important for maintaining a good quality of life and independence as women age.13579
What safety data exists for Inspiratory Muscle Training in postmenopausal women?The provided research does not contain specific safety data for Inspiratory Muscle Training (IMT) or related devices like PrO2 Fit (IMT Trainer) in postmenopausal women. The studies focus on resistance training, body composition, and muscle strength in postmenopausal women, but do not address the safety or efficacy of IMT devices. Further research specifically targeting IMT would be needed to provide relevant safety data.12457
What data supports the idea that Inspiratory Muscle Training for Postmenopausal Women is an effective treatment?The available research shows that Inspiratory Muscle Training (IMT) can be effective for improving physical outcomes in pre-frail older women. One study specifically looked at adding IMT to whole body vibration exercises and found it beneficial for functional and physical performance. This suggests that IMT can be a helpful addition to exercise routines for postmenopausal women, potentially improving their physical abilities and overall health.15678
Do I need to stop taking my current medications for the trial?Yes, you must stop taking prescription medications that affect heart rate or blood vessel dilation, such as systemic beta-adrenergic blockers, calcium channel blockers, and hormone replacement therapy.
Eligibility Criteria
This trial is for postmenopausal women who are interested in how strengthening breathing muscles might improve heart health and mood. Details on specific inclusion or exclusion criteria were not provided, so it's best to contact the study team for more information.Inclusion Criteria
I can walk on my own without help.
I am a woman who has not had a menstrual cycle for at least 6 years.
I am between 50 and 75 years old.
Exclusion Criteria
I am unable to understand or sign the consent form.
I am planning to have surgery during the study.
I am taking medication that affects my heart rate or blood vessels.
I have been diagnosed with an aneurysm in my chest, abdomen, or brain.
My blood pressure is not higher than 159/99 mm Hg.
I have severe joint problems or reasons I can't do hard exercise.
I have a history of heart conditions or heart attack.
I have been diagnosed with asthma or chronic lung disease.
I currently have a respiratory infection.
Treatment Details
The trial is testing a device called PrO2 Fit, which is an Inspiratory Muscle Training (IMT) trainer. It aims to see if using this device can help with cardiovascular health and reduce mood disturbances in postmenopausal women.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inspiratory Muscle Training (IMT) groupExperimental Treatment1 Intervention
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 4 times a week, and over 8-weeks.
Group II: Sham Inspiratory Muscle Training (Sham-IMT) groupPlacebo Group1 Intervention
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 4 times a week, and over 8-weeks.
PrO2 Fit (IMT Trainer) is already approved in United States for the following indications:
🇺🇸 Approved in United States as PrO2 Fit for:
- Rehabilitation for respiratory conditions
- Improvement of respiratory muscle strength and endurance
Find a clinic near you
Research locations nearbySelect from list below to view details:
Indiana UniversityBloomington, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
References
Effects of resistance training and soy isoflavone on body composition in postmenopausal women. [2022]Objective. To investigate the independent and additive effects of resistance training (RT) and soy isoflavone (ISO) on body composition in postmenopausal women (PW). Method. This study used a placebo-controlled, double-blind (soy), randomized (ISO versus placebo) x (RT versus No RT) design. A total of 80 PW, aged 45-70 years, were randomly (71 completed 9-months intervention): RT + ISO (n = 15), No RT + ISO (n = 20), RT + placebo (n = 18), and No RT + placebo (n = 18). ISO received 100 mg a day of isoflavone; and to RT attended supervised resistance training sessions. At baseline and 9-months, fat and muscle mass were estimated by DXA. ANOVA and test t were used. Results. RT groups showed significantly increased muscle strength (35.2%) and muscle mass (1.4%). Exercising attenuated gains in fat trunk and % body fat (P
Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. [2015]This study aimed to examine the efficacy of creatine supplementation, associated or not with resistance training, in vulnerable older women. A 24-week, double-blind, randomized, placebo-controlled trial was performed. Sixty subjects were assigned to compose the following groups: placebo (PL), creatine supplementation (CR), placebo with resistance training (PL+RT), and creatine supplementation with resistance training (CR+RT). The subjects were assessed at baseline and after 24weeks. The primary outcome was muscle strength, as assessed by one-repetition maximum (1-RM) tests. Secondary outcomes included appendicular lean mass, bone mass, biochemical bone markers, and physical function tests. The changes in 1-RM leg press were significantly greater in the CR+RT group (+19.9%) than in the PL (+2.4%) and the CR groups (+3.7%), but not than in the PL+RT group (+15%) (p=0.002, p=0.002, and p=0.357, respectively). The CR+RT group showed superior gains in 1-RM bench press (+10%) when compared with all the other groups (p≤0.05). The CR+RT group (+1.31%) showed greater appendicular lean mass accrual than the PL (-1.2%), the CR (+0.3%), and the PL+RT groups (-0.2%) (p≤0.05). The CR and the PL+RT groups experienced comparable gains in appendicular lean mass (p=0.62), but superior to those seen in the PL group. Changes in fat mass, bone mass and serum bone markers did not significantly differ between the groups (p>0.05). In conclusion, creatine supplementation combined with resistance training improved appendicular lean mass and muscle function, but not bone mass, in older vulnerable women. Clinicaltrials.gov: NCT01472393.
Twelve weeks' progressive resistance training combined with protein supplementation beyond habitual intakes increases upper leg lean tissue mass, muscle strength and extended gait speed in healthy older women. [2022]The age-related decline in functional capability is preceded by a reduction in muscle quality. The purpose of this study was to assess the combined effects of progressive resistance training (PRT) and protein supplementation beyond habitual intakes on upper leg lean tissue mass (LTM), muscle quality and functional capability in healthy 50-70 years women. In a single-blinded, randomized, controlled design, 57 healthy older women (age 61.1 ± 5.1 years, 1.61 ± 0.65 m, 65.3 ± 15.3 kg) consumed 0.33 g/kg body mass of a milk-based protein matrix (PRO) for 12 weeks. Of the 57 women, 29 also engaged in a PRT intervention (PRO + PRT). In comparison to the PRO group (n = 28), those in the PRO + PRT group had an increase in upper leg LTM [0.04 (95% CI -0.07 to 0.01) kg vs. 0.13 (95% CI 0.08-0.18) kg, P = 0.027], as measured by Dual-energy X-ray absorptiometry; an increase in knee extensor (KE) torque [-1.6 (95% CI -7.3 to 4.4 N m) vs. 10.2 (95% CI 4.3-15.8 N m), P = 0.007], as measured from a maximal voluntary isometric contraction (Con-Trex MJ; CMV AG); and an increase in extended gait speed [-0.01 (95% CI -0.52-0.04) m s-1 vs. 0.10 (95% CI 0.05-0.22) m s-1, P = 0.001] as measured from a maximal 900 m effort. There was no difference between groups in the time taken to complete 5 chair rises or the number of chair rises performed in 30 s (P > 0.05). PRT in healthy older women ingesting a dietary protein supplement is an effective strategy to improve upper leg LTM, KE torque and extended gait speed in healthy older women.
Moderate-Intensity Continuous Training or High-Intensity Interval Training with or without Resistance Training for Altering Body Composition in Postmenopausal Women. [2021]This study aimed to compare body composition changes induced by moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or HIIT + resistance training (RT) programs (3 d·wk, 12 wk) in overweight/obese postmenopausal women, and to determine whether fat mass reduction is related to greater fat oxidation (FatOx).
Resistance Training as Treatment for Sarcopenia: Examining Sex-Related Differences in Physiology and Response. [2022]Sarcopenia or muscle mass atrophy reportedly occurs in up to 50% of those aged >80 years and is a significant risk factor for functional disability and poor physical performance. Over time, the deterioration in both skeletal muscle quality and composition may compromise functional independence and has been shown to independently increase the risk for falls, fractures, and overall poor health in the elderly population. These are seen most obviously in older women. Given these serious consequences, much effort has been directed toward promoting increased activity and resistance training for muscle maintenance or even muscle regeneration in older adults. The Centers for Disease Control and Prevention states that for all adults ≥65 years of age, weekly aerobic and strength training are vital to healthy aging. Older patients who have not previously participated in strength training may be hesitant about starting a resistance training program and resort to simple and familiar aerobic exercise options such as walking, jogging, or cycling. However, the benefits of strength training are too important to miss: it can improve skeletal muscle metabolic capacity, mitigate effects of aging on functional capacity, maintain bone density, and, most importantly, help individuals maintain a higher quality of life and independence. Due to their increased risk of disability and injury, this opportunity for "exercise as medicine" is particularly important to women and must be encouraged by clinicians. As such, the purpose of this commentary was to highlight known sex-related differences in muscle metabolism and potential benefits of resistance training for elderly patients. A comprehensive understanding of the issues and prevention measures presented here may allow clinicians to better serve their patients, especially older female patients, and, ultimately, alleviate the burden placed on our society by our rapidly aging population.
Inspiratory muscle training in addition to whole body vibration for functional and physical outcomes in pre-frail older women: a randomized controlled trial. [2022]to investigate the efficacy of addition of inspiratory muscle training (IMT) to the whole body vibration (WBV) on functional outcomes, physical performance, muscle strength and metabolism in pre-frail older women.
The impact of resistance training on body composition, muscle strength, and functional fitness in older women (45-80 years): A systematic review (2010-2020). [2022]As women age, they typically experience a progressive decrease in skeletal muscle mass and strength, which can lead to a decline in functional fitness and quality of life. Resistance training (RT) has the potential to attenuate these losses. Although well established for men, evidence regarding the benefits of RT for women is sparse and inconsistent: prior reviews include too few studies with women and do not adequately examine the interactive or additive impacts of workload, modalities, and nutritional supplements on outcomes such as muscle mass (MM), body composition (BC), muscle strength (MS), and functional fitness (FF). The purpose of this review is to identify these gaps. Thirty-eight papers published between 2010 and 2020 (in English) represent 2519 subjects (mean age = 66.89 ± 4.91 years). Intervention averages include 2 to 3 × 50 min sessions across 15 weeks with 7 exercises per session and 11 repetitions per set. Twelve studies (32%) examined the impact of RT plus dietary manipulation. MM, MS, and FF showed positive changes after RT. Adding RT to fitness regimens for peri- to postmenopausal women is likely to have positive benefits.
HR-pQCT for the Evaluation of Muscle Quality and Intramuscular Fat Infiltration in Ageing Skeletal Muscle. [2023]Myosteatosis is the infiltration of fat in skeletal muscle during the onset of sarcopenia. The quantification of intramuscular adipose tissue (IMAT) can be a feasible imaging modality for the clinical assessment of myosteatosis, important for the early identification of sarcopenia patients and timely intervention decisions. There is currently no standardized method or consensus for such an application. The aim of this study was to develop a method for the detection and analysis of IMAT in clinical HR-pQCT images of the distal tibia to evaluate skeletal muscle during the ageing process, validated with animal and clinical experimentation. A pre-clinical model of ovariectomized (OVX) rats with known intramuscular fat infiltration was used, where gastrocnemii were scanned by micro-computed tomography (micro-CT) at an 8.4 μm isotropic voxel size, and the images were analyzed using our modified IMAT analysis protocol. IMAT, muscle density (MD), and muscle volume (MV) were compared with SHAM controls validated with Oil-red-O (ORO) staining. Furthermore, the segmentation and IMAT evaluation method was applied to 30 human subjects at ages from 18 to 81 (mean = 47.3 ± 19.2). Muscle-related parameters were analyzed with functional outcomes. In the animal model, the micro-CT adipose tissue-related parameter of IMAT% segmented at −600 HU to 100 HU was shown to strongly associate with the ORO-positively stained area (r = 0.898, p = 0.002). For the human subjects, at an adjusted threshold of −600 to −20 HU, moderate positive correlations were found between MV and MD (r = 0.642, p
Adaptations to a Concurrent Exercise Training Program in Inactive Aging Women. [2022]Wadsworth, DD, Rodriguez-Hernandez, M, Huffman, LS, McDonald, JR, Spring, KE, and Pascoe, DD. Adaptations to a concurrent exercise training program in inactive aging women. J Strength Cond Res 36(11): 3217-3223, 2022-This study assessed the effect of a 10-week, sprint interval concurrent exercise training program on body composition and muscular strength in aging women. Sixty-five inactive women (age, 40-64 years) were randomized into 2 sprint interval exercise programs, 0% incline and 6% incline. Sprint interval training was performed to achieve 95% of each subject's age-predicted maximal heart rate for a series of 40 seconds of work followed by 20 seconds of passive recovery. An undulating resistance training protocol, composed of 30 sessions, was performed by each group throughout the study. Dual-energy X-ray absorption scans were assessed body composition, and 1 repetition maximum was performed to assess muscular strength. Subjects in both groups significantly reduced fat mass by approximately 0.35 kg ( p = 0.002), and visceral adipose tissue by 0.05 kg ( p = 0.032). There were significant increases in lean body mass by approximately 0.50 kg ( p = 0.005), lower-body muscular strength by approximately 46.83 kg ( p