Respiratory Muscle Endurance Training in Healthy Elderly

NCT03730935 | Completed

• 1 other identifier: RETE_2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Prevalence of hypertension in the elderly is high. Given that hypertension is the leading cause of cardiovascular disease worldwide, safe and efficacious treatment options for this condition are highly desired. Apart from medication, changes in lifestyle are recommended to lower blood pressure, such as an increase in physical exercise. However, whole-body exercise is not feasible for all. Mobility disabilities, for example, increase sharply with age and are already common in middle age. For this population, it is necessary to have alternative, non-invasive interventions with similar effects on blood pressure. One such intervention might be respiratory muscle endurance training (RMET), but the effects on blood pressure are currently unknown. The primary aim of this project is therefore to investigate the effects of RMET over the course of several weeks on resting blood pressure in healthy elderly. The secondary aim of the project is to evaluate the effects of RMET on uphill exercise performance in healthy active elderly given that elderly experience structural and functional changes of the lungs potentially affecting exercise performance. Finally, since prevalence of subjective sleep complaints is also high in the elderly, the present study will also investigate the effects of RMET on sleep quality.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Change in systolic and diastolic blood pressures (in mmHg) between baseline and after one month of training. Measurements will be done in triplicate after at least 10 minutes of quiet lying on a stretcher

  At baseline and after completion of the study (approximately one month)

Secondary Outcomes (8)

• Incremental test

  At baseline and after completion of the study (approximately one month)

• Endurance capacity test

  At baseline and after completion of the study (approximately one month)

• Sleep efficiency

  At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

• Sleep onset latency

  At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

• Fragmentation index

  At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

Study Arms (2)

Intervention

EXPERIMENTAL

Respiratory muscle endurance training (30 minutes of volitional hyperpnoea at a target ventilation of 60-70% of the individual maximal voluntary ventilation for 5 days per week for 4 weeks).

Device: Respiratory muscle endurance training

Sham

SHAM COMPARATOR

Sham training will be performed 5 times a week for 4 weeks using a mock asthma inhaler filled with 5.5 mg lactose powder. Subjects will be instructed to inhale the powder according to inhaler instructions and to then perform one full inspiration to total lung capacity using custom-made, low resistance tubing, which elicits minimal resistance to breathing.

Device: Respiratory muscle endurance training

Interventions

Respiratory muscle endurance training DEVICE

Respiratory muscle endurance training performed over the duration of 4 weeks

Intervention; Sham

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 55-80 years
• Active (according to World Health Organisation Criteria)
• Systolic blood pressure lower than 140 mmHg and diastolic blood pressure lower than 90 mmHg
• Non-smoking
• Body-Mass-Index (BMI): 18.5-29.9 kg·m-2
• Normal lung function

You may not qualify if:

• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Intake of blood pressure medication or history of hypertension
• Intake of medications affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system
• Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Zurich, Canton of Zurich, 8057, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 5, 2018
• Study Start: December 7, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

CH (1)