RightFit
RecruitingNot applicable

IMST for Dementia Risk Reduction

Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests breathing muscle strength training (IMST) at home for 8 weeks in adults ages 60–80 who have a risk factor for dementia. It will check whether the training is practical and may lower risks to heart health, memory, and thinking. It will also look at mood, sleep, inflammation, movement, and how well people follow and like the program.

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 60–80 years old.
  • Your converted score on the telephone MoCA, a memory and thinking test, is at least 18.
  • You have at least one dementia risk factor, such as mild thinking problems, memory concerns, high blood pressure, little exercise, family history, a reported APOE ε4 gene, or mild breathing problems during sleep. The criteria also list a CAIDE dementia risk score above 5.
  • You can do the breathing training on your own or with little help.
  • You are willing to train about 5–10 minutes a day for 8 weeks.
  • The study will also check for weak breathing muscles. This is listed as an optional requirement.

Who can't join

  • Your telephone MoCA score is below 18, or the study leader decides you have a disease that damages brain or nerve function. Mild cognitive impairment, meaning mild thinking problems, is allowed.
  • You have a major mental health disorder, such as psychosis, bipolar disorder, or severe depression with a PHQ-9 score above 20, as judged by the study leader.
  • You have unstable heart or lung disease, or an injury to your lungs or eardrums.
  • You recently had breathing therapy or major changes to your medicines.
  • You report severe untreated or unstable sleep apnea, a condition that makes breathing stop and start during sleep.
  • You started CPAP or BiPAP, machines that help with breathing during sleep, within the past month, or recently used breathing muscle training.
  • You do not speak English.
  • If you have a pacemaker or another medical implant with magnets or electronics, you cannot take part in body composition tests, which measure things like body fat and muscle. This does not exclude you from the whole study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Ages 60-80 * Converted telephone MoCA total score≥18 * Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \[SBP \>130 mmHg or on medication\], sedentary lifestyle \[\<150 min/week\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \[\>5\] * Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST) * Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks) * Optional inclusion of inspiratory muscle weakness (MIP \<80 cmH₂O for men, \<70 cmH₂O for women) will also be assessed. Exclusion Criteria: * tMoCA \<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI) * Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \> 20) * Unstable cardiovascular or pulmonary disease * Recent respiratory therapy or major medication changes * Self-reported severe untreated or unstable obstructive sleep apnea (OSA) * Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training * Lung and eardrum injuries * Non-English speaking * Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.

Study sites (1)

FL