Breath of Life

In 2021 as the pandemic surged, Dr. Karl Krupp, a professor of Public Health at the University of Arizona, noted that many critically ill patients were ending up on invasive mechanical ventilation to support their breathing (IMV). While necessary to help with breathing, many of these patients – intubated because they were experiencing Acute Respiratory Distress Syndrome (ARDS) – then lost the capacity to breathe while on lung support.

“These people needed to increase their inspiratory strength when they came off ventilation. I think that’s where I became interested,” said Dr. Krupp.

His idea had its genesis in earlier studies on inspiratory muscle training (IMT) to reduce fatigue and improve athletic performance in college track runners.   

“I started looking into the literature and found some people at the University of Colorado who were working on hypertension using an Inspiratory Muscle Strength Training (IMST) device. Incidentally, they noticed that people’s systolic blood pressure went down when they started exercising their lung muscles. It raised the question, can we actually use this as an intervention for hypertension?”

An older man uses a breathing device
In the pilot study, a participant uses the POWERbreathe Plus Medium Resistance breath trainer (images courtesy: PHRII)

What is IMST?

IMST – or resistive breath training is a technique that improves the respiratory function of high-intensity athletes or post-surgical patients. Its non-invasive technology is simple to use and it has health benefits like lowering blood pressure and strengthening the complex muscles involved in breathing. Dr. Krupp recognized the inherent potential of the IMST technique for elderly people who had breathing problems. 

“I became very interested in this idea that we’re going up against the paradigm in pulmonology circles that once your lungs decline, they can’t be rejuvenated. The way that medical experts look at it, you reach your peak in pulmonary capacity at 25 (years of age) and it’s all downhill from there.”

“It seemed possible, looking at patients coming off ventilation, that what we believed about pulmonary health was untrue and that we have a way to strengthen people’s lungs.”

“That was where the thought process took me,” said Dr.Krupp whose research interests focus on aging and frailty. “Can we apply the IMST protocols used for hypertension, to aging?”

To find out, he traveled halfway across the world to India and set up a study in the southern town of Mysore. What took an American professor of public health from the southwestern state of Arizona to test his hypothesis in rural India?

A man stands in front on a window and a wall of images as he talks
Dr. Karl Krupp, MSc, PhD, at PHRII in Mysore, India, explained how the pilot IMST study in Mysore began. Dr. Krupp is an Assistant Professor in the Division of Public Health Practice & Translational Research in the Mel & Enid Zuckerman College of Public Health at the University of Arizona. (image credit: Meera Kymal)

The answer lies in an unusual story about public health and its global reach.

A clinic from scratch

In 2005, Dr. Krupp’s wife, HIV physician, and epidemiologist Dr. Purnima Madhivanan was completing her PhD dissertation research on public health in India. She set up a temporary reproductive health clinic in Mysore to provide free medical care to rural women of reproductive age who had no access to healthcare.

The couple sold their home, their Maruti car, and belongings to bootstrap the clinic. They hired and trained local women as outreach workers, an initiative embraced by the local community and its patients. “We achieved a 96% retention rate unheard of in India,” said Dr. Purnima in an interview. The couple decided to make the clinic a permanent facility, and in 2007 co-founded the Public Health Research Institute of India (PHRII), a non-profit charitable trust.

Purnima Madhivanan, MBBS, MPH, PhD, is a tenured Associate Professor in the Department of Health Promotion Sciences at the Mel and Enid Zuckerman College of Public Health at the University of Arizona (image credit: LinkedIn)

Since 2009, PHRII has offered outpatient services and mobile clinics for family planning, reproductive healthcare, and cancer screening to low-income communities in the villages outside Mysore. Located in the quiet Yadavgiri neighborhood of Mysore, a team of clinicians plans and implements public health programs in Mysore District.

Today PHRII is recognized for its landmark research and its training of Global Health scholars to address systemic health inequities experienced by the most disadvantaged populations. Students from U.S. universities undertake internships here in programs that promote healthcare access through research, training, advocacy, and care.

A group of people sit outside a  building, a research facility in Mysore, India
The PHRII team at their headquarters in Mysore, India (image courtesy: LinkedIn)

A readymade setting

PHRII’s setting offered a readymade venue to explore the feasibility of IMST in an aging population. IMST shows promise for lowering hypertension, but little is known about its use among older Indian adults. Would villagers in Mysore District be amenable to using a breathing device and make such a study feasible?

In November 2023, Dr. Krupp shared a poster on the pilot study “Feasibility and Acceptability of Inspiratory Muscle Strength Training among Older Adults” at the Gerontological Society of America (GSA) annual convention in Tampa Florida. While initial findings appear promising, said Dr. Krupp, he cautioned it was just a preliminary study and foresees a long road ahead to scale-up of clinical trials that can demonstrate that it’s an effective intervention for improving the health of aging adults.

The poster on the IMST clinical study in Mysore, India, presented at the GSA annual meeting in Tampa, FL, November 2023, by Dr. Karl Krupp; (image credit: Meera Kymal)

Novel lifestyle intervention

At PHRII in Mysore, principal investigator Dr. Raghavi Karanam explained that the pilot IMST study focused on a sample of elders over 65 years old, from four rural villages in Mysore District. The aim was to assess the feasibility and acceptability of a breathing exercise intervention for older adults with hypertension. Unlike urban settings, older people in villages had fewer options to exercise, she added. “These senior citizens are very sedentary, after the age of 65.”  

Selection criteria

Participants were selected based on specific criteria such as mental status, cognitive, and physical fitness. A 25-minute pre-assessment analyzed physical parameters focused on balance and the time taken to cover a distance. Dr. Raghavi clarified the screening excluded people with comorbidities such as arthritis, for example, an associated condition for this age group that could affect the study. “They have to breathe against the device, so we were very careful in selecting a population without cardiac issues.” The assessment also ensured that eligible participants possessed good dental health or at least a set of dentures to hold the device in place. 

A woman stares thoughtfully
Dr. Raghavi Karanam, MBBS, MD(OBG), DNB(OBG), research physician at PHRII discusses protocols used in the study (image credit: Meera Kymal)

The IMST Breath Trainer

To breathe with an IMST, participants hold the device in their mouths, clenching it with their jaws to avoid air gaps, and then take a deep breath. The device has a 0-10 scale which when tightly closed offers zero resistance.

“It’s very easy to breathe in and out,” confirms Dr. Raghavi. As resistance settings are increased, breathing (inspiration) becomes a challenge but blowing out (expiration) is easy. Taking a deep breath against resistance exercises the inspiratory muscles of the lung and increases capacity – similar to increasing weights in a weight training exercise.

Studies show that as people age their breathing deteriorates. The shortness of breath that older people experience can manifest as an intense tightening in the chest or a feeling of breathlessness – a common geriatric condition among older adults known medically as dyspnea (NIH). Aging impacts the respiratory system and the bones and muscles that aid breathing. Taking deep breaths drives oxygen to their lungs, organs, muscles, and bones, which ‌in turn enhances overall health and aging well.

But Mysore’s villagers were not easily convinced by the new technology. “The villagers were afraid there was medicine inside the device. We had to convince them it was safe to use,” said Dr. Raghavi, who shared ads of popular cricketer Virat Kohli promoting the device to reassure the skeptics. “We were able to motivate people to use them!”

A youth supervisor watches one of his charges practicing on her breath trainer
A youth supervisor watches as one of the older adults assigned to him practices her breathing technique on the IMST device (image courtesy: PHRII)

Breathing Protocol

Between November 2022  and January 2023, thirty-one non-smoking adults aged 65-80 years with blood pressure >140/90 mm Hg enrolled in the study and were introduced to the POWERbreathe Plus Medium Resistance breath trainer.

They first practiced the IMST technique over a two-week period during which they held the device in place with their jaws while continuing to breathe, a process that initially felt awkward.

In the first day or so, perhaps because participants were unused to performing the breathing intake, a few experienced heaviness in the head, giddiness, or tightness in the chest. “That’s when we stopped,” explained Dr. Raghavi. “Sometimes older people are only able to manage three breaths after which we asked them to rest. But every day, they grew more comfortable, even with increasing resistance.”

Once they were comfortable, participants followed a breathing protocol – 30 breaths a day, 5 days a week for 6 weeks. They attempted 6 breathing cycles a day of 5 to 6 breaths per cycle, separated by a minute’s break in between. Each cycle lasted about 2 to 3 minutes. “We ask them to take a deep breath, hold it, and then breathe out,” said Dr. Raghavi.

A woman breathes with an IMST device as a man looks on
A participant exercises with her IMST device as her youth supervisor looks on (image courtesy: IMHRII)

Setting Resistance

Younger, fitter athletes can use an IMST device set at a 50 -70% rate of resistance. However, the 65+ year-olds in the trial needed a lower rate of resistance. After a two-week introduction with zero resistance and random testing of basic parameters such as blood pressure, “we set the device at a minimal resistance of about 10%,” said Dr. Raghavi.

A man breathes through an IMST device
A male participant practices his IMST technique (image courtesy: PRHII)

Resistance was raised gradually every week as the trial progressed. Some participants found it challenging to handle higher resistance and experienced breathlessness. If a participant was unable to maintain 30 breaths a minute as the range increased, they were returned to the 10% rate of resistance.

Occasionally, there were dropouts. One woman left because she experienced eye pain following cataract surgery and had difficulty breathing through the device; another was unable to hold the device because of dental limitations.

Intergenerational Supervision & WhatsApp

A unique aspect of the project was training young supervisors to work daily with elders to monitor the use of the breath trainer. “We selected 5 youths from each community who became responsible for 5 participants,” said Dr. Raghavi. That dynamic worked because each group quickly developed a rapport with their assigned youth supervisor whom they knew from their village. The participants, said Dr. Krupp, looked forward to a young person visiting them.

Over 25 youth supervisors were hired during the study to visit their designated households each morning and supervise each 10–15-minute exercise session. They kept tabs on their charges, reporting on their performance during each intervention, and sent pictures of daily readings via WhatsApp (the most popular social media platform among South Asians) back to the clinic. Clinic staff regularly monitored the reports, checking in with participants and youth supervisors every week.

A training session for youth supervisors in the IMST study in Mysore, India (image courtesy: PRHII)

The Outcome

After 6 weeks participants were evaluated by a physical exam and a survey to collect data on physical performance and comfort levels with the device. They assessed objective measures such as gait, speed, and balance, as well as cognition, depression, and pulmonary function.

Overall, said Dr. Krupp, the subjective measures were positive. Participants who had previously experienced breathlessness when walking even a short distance said breathing felt easier. Others said they felt lighter and better, sharing indicators like ‘my chest is clear now,’ ‘my gastritis has reduced,’ ‘I’m sleeping better,’ and ‘I’m walking faster.’



There was a definite improvement said Dr. Raghavi. Participants expressed that the device was easy to use and would recommend it to other elders in the community.

They felt their mental health was better because the intervention improved their balance. “We definitely saw borderline improvement in their blood pressure levels. There was a positive shift. It’s promising. This experience has taught us what is feasible.”

A group of people watch an older woman using an IMST device
Clinic staff and supervisors monitor a participant (image courtesy/ PRHII)

Deep Breathing Feels Good

“My impression was that most of the people were successful,” said Dr. Krupp. “Essentially, you want them to adhere, fully complete the exercise, and follow the protocols. They felt comfortable and were positive about doing the exercise.” As participants started to feel more able to carry out the exercises they went along. “So that in itself, that success, sort of contributed to their overall feeling that they wanted to continue and that was good.”

While he noted a dramatic improvement across all of the measures, Dr. Krupp cautioned that these results were preliminary findings. “We don’t want to generalize the results of our users to a larger population without having more people as a sample. Our next step is to increase the sample rate dramatically, and then focus on the objective measures.”

Scaling up the study

A plan is underway to scale up the study with the possibility of funding through the NIH to do a project in the summer of 2024.

 “It’s going to be a more pragmatic trial,” said Dr. Krupp. “We’ll try to adapt the lessons we learned on the first one and involve a biostatistician to calculate how many participants we will need to gain good estimates of the health benefits of the intervention.”

Scaling up in a rural setting is more complicated added Dr. Raghavi, because training additional youth supervisors and training elders to be self-motivated to use the device is not an easy task. “Monitoring usage, exercise, hypertension, and inclusion criteria for a bigger study get more challenging,” she explained.

Dr. Krupp used startup funds from the University of Arizona to purchase the IMST devices for the pilot. “This is one of those bootstrap projects that we wanted originally to have some data that we could present to the NIH to convince them that this is a worthwhile project,” he said.

“Then we will know how to power a much bigger trial that the NIH would hopefully support. It would be a big five-year study where we ramp up and get some results that’s generalizable to a larger population.”

Krupp expects the intervention could become widely available in the U.S. and other countries if they can demonstrate that the intervention will improve health outcomes for older people.

The overall benefit we hope, says Dr.Krupp, is that older people who have difficulty exercising regularly can still improve their lung capacity, and get many of the benefits of aerobic exercise in an age-friendly intervention. 

This article was written with the support of a journalism fellowship from The Gerontological Society of America, The Journalists Network on Generations, and The John A. Hartford Foundation.

References

https://publichealth.arizona.edu/directory/karl-krupp

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0244963

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830231/

https://www.uclahealth.org/news/imst-breathing-exercises-can-help-lower-blood-pressure

https://www.colorado.edu/today/2021/06/29/5-minute-breathing-workout-lowers-blood-pressure-much-exercise-drugs

https://publichealth.arizona.edu/directory/purnima-madhivanan

https://www.phrii.com/welcome#why-we-do-it

https://www.linkedin.com/company/public-health-research-institute-of-india-phrii/

https://www.lung.org/blog/your-aging-lungs

Meera Kymal is the Managing Editor at India Currents and Founder/Producer at desicollective.media. She produces multi-platform content on the South Asian diaspora through the lens of social justice,...