Effectiveness of Inspiratory Muscle Training With Slow Breathing in Elderly With ISH
1 other identifier
interventional
32
1 country
1
Brief Summary
Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in elderly with Isolated systolic hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Mar 2016
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedApril 26, 2016
April 1, 2016
2.3 years
April 7, 2016
April 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Maximal inspiratory pressure (MIP)
MIP will be measure by Mouth pressure meter (Micro RPM, Micro Medical, Inc., Chatham Maritime, Kent)
Baseline and at 8 weeks
Secondary Outcomes (4)
Lung capacity
Baseline and at 8 weeks
Exercise capacity
Baseline and at 8 weeks
Chest wall expansion and abdominal expansion
Baseline and at 8 weeks
Blood pressure (BP)
Baseline and at 8 weeks
Study Arms (2)
Inspiratory Muscle Training (IMT)
EXPERIMENTALSubjects in the inspiratory muscle training (IMT) group will perform loaded deep breathing exercise at 6 breaths/min using BreatheMaxยฎ device. The IMT protocol at 6 breathing rate (inspiratory time = 4 seconds and expiratory time = 6 seconds) with load at 25 percent of MIP for eighth weeks. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks
Control
PLACEBO COMPARATORSubjects in the control (CON) group will perform breathing exercise with inspiratory load at 2 cmH2O at 6 breathing rate using one BreatheMAXยฎ device. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks
Interventions
Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
Eligibility Criteria
You may qualify if:
- Subjects aged 60 to 80 years of age with an essential isolated systolic hypertension stage I II based on recommendation of JNC VII from primary care units in community and the Outpatient Department of Srinakarind hospital in Khon Kaen province Thailand
- Good communication and co operation
- Independent physical activity
- Stable controlled hypertension
You may not qualify if:
- Essential isolated systolic hypertension stage III or secondary hypertension
- History of heart disease such as coronary artery disease myocardial infarction
- History of respiratory disease such as asthma chronic bronchitis
- History of neuromuscular disease such as muscle weakness cerebrovascular disease
- History of renal disease
- Exercise limited by pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Associated Medical Sciences
Na Muang, Changwat Khon Kaen, 40002, Thailand
Related Publications (2)
Jones CU, Sangthong B, Pachirat O. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial. J Physiother. 2010;56(3):179-86. doi: 10.1016/s1836-9553(10)70023-0.
PMID: 20795924RESULTUblosakka-Jones C, Tongdee P, Pachirat O, Jones DA. Slow loaded breathing training improves blood pressure, lung capacity and arm exercise endurance for older people with treated and stable isolated systolic hypertension. Exp Gerontol. 2018 Jul 15;108:48-53. doi: 10.1016/j.exger.2018.03.023. Epub 2018 Mar 28.
PMID: 29604403DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Phailin Tongdee, Master
Faculty of Associated Medical Sciences.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Effectiveness of inspiratory muscle training with antihypertensive breathing technique on lung and exercise capacity in elderly with isolated systolic hypertension
Study Record Dates
First Submitted
April 7, 2016
First Posted
April 26, 2016
Study Start
March 1, 2016
Primary Completion
July 1, 2018
Study Completion
September 1, 2018
Last Updated
April 26, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share