Respiratory Muscle Endurance Training in Healthy Elderly

NCT ID: NCT03730935

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2019-05-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Intervention

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).

Group Type: EXPERIMENTAL

Respiratory muscle endurance training

Intervention Type: DEVICE

Respiratory muscle endurance training performed over the duration of 4 weeks

Sham

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.

Group Type: SHAM_COMPARATOR

Respiratory muscle endurance training

Intervention Type: DEVICE

Respiratory muscle endurance training performed over the duration of 4 weeks

Interventions

Respiratory muscle endurance training

Respiratory muscle endurance training performed over the duration of 4 weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

RETE_2018

Identifier Type: -

Identifier Source: org_study_id