Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker

Pacemaker Clinical Trial

Official title:

Effects of Inspiratory Muscle and Endurance Training on Exercise Capacity, Respiratory Muscle Strength and Endurance and Quality of Life in Heart Failure Patients With Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501355
• Other study ID #: Gazi University 7
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is well-known that not only peripheral muscles, but also respiratory muscles muscle weakness and deconditioning play an important role in low exercise capacity of patients with Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and quality of life in patients with heart disease. However, hearth failure patients with pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing exercise. No study investigated the effects of different inspiratory muscle training protocols. For this reason, we aimed to investigate the effects of inspiratory muscle training on outcomes in hearth failure patients with pacemaker

Description:

Heart failure patients with pacemaker will be included. Primary outcome measurement is respiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression, physical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Heart failure patients with Pacemaker who are clinically stable
• After 12 weeks of pacemaker implantation
• No change in medications over one month Exclusion Criteria: Patients with
• Severe cognitive disorders
• Pulmonary, neurological and orthopedic diseases
• Pregnant and lactating patients
• Acute infection or exacerbation

Related Conditions & MeSH terms

• Heart Failure
• Pacemaker
• Respiratory Aspiration

Intervention

Device:
• Inspiratory muscle strength training
Treatment group will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 50% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 50% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
• Inspiratory muscle endurance training
Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Alswyan AH, Liberato ACS, Dougherty CM. A Systematic Review of Exercise Training in Patients With Cardiac Implantable Devices. J Cardiopulm Rehabil Prev. 2018 Mar;38(2):70-84. doi: 10.1097/HCR.0000000000000289. — View Citation

Belardinelli R, Capestro F, Misiani A, Scipione P, Georgiou D. Moderate exercise training improves functional capacity, quality of life, and endothelium-dependent vasodilation in chronic heart failure patients with implantable cardioverter defibrillators and cardiac resynchronization therapy. Eur J Cardiovasc Prev Rehabil. 2006 Oct;13(5):818-25. — View Citation

Dougherty CM, Glenny RW, Burr RL, Flo GL, Kudenchuk PJ. Prospective randomized trial of moderately strenuous aerobic exercise after an implantable cardioverter defibrillator. Circulation. 2015 May 26;131(21):1835-42. doi: 10.1161/CIRCULATIONAHA.114.014444. Epub 2015 Mar 19. — View Citation

Isaksen K, Munk PS, Giske R, Larsen AI. Effects of aerobic interval training on measures of anxiety, depression and quality of life in patients with ischaemic heart failure and an implantable cardioverter defibrillator: A prospective non-randomized trial. J Rehabil Med. 2016 Mar;48(3):300-6. doi: 10.2340/16501977-2043. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Exercise capacity	Incremental Shuttle Walk Test	First day
Secondary	Inspiratory and expiratory muscle strength (MIP, MEP)	Mouth pressure device	First day
Secondary	Peripheral muscle strength	Hand held dynamometer	First day
Secondary	Pulmonary functions	Spirometry	First day
Secondary	Fatigue	Fatigue Severity Scale (FSS) (Turkish version of scale) Patient choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue	Second day
Secondary	Quality of life	Short Form (SF-36) Health Survey (Turkish version of scale) The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning (10 items) social functioning (2 items) role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items). For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).	Second day
Secondary	Depression	Montgomery Asberg Depression Rating Scale (MADRS) (Turkish version of scale) This assessment tool contains 10 items with a score from 0 to 6, thus the maximum score is 60. A higher score indicates a more severe depression.	Second day
Secondary	Physical activity	International Physical Activity Questionnaire (IPAQ) - Short Form (Turkish version of scale ) This questionnaire assesses, in minutes, the physical activity performed by the volunteers during the period of one week. The IPAQ considered all activities carried out by the volunteer (e.g. leisure, sport, exercise, and activities at home or in the garden). According to the responses, the volunteer is considered very active, active, irregularly active or sedentary, according to the intensity and time of the exercises practiced over the last week.	Second day
Secondary	Health-related quality of life	Minnesota Living with Heart Failure Questionnaire (MLHFQ) (Turkish version of scale) 21 items rated on six-point Likert scales, representing different degrees of impact of HF on Heart Related Quality of Life (HRQoL), from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25).	Second day
Secondary	Cognitive function	Mini mental state examination (MMSE)(Turkish version of scale ) The scale has a maximum score of 30 points. The questions have been grouped into seven categories, each rationally representing a different cognitive domain or function: Orientation to time (5 points); Orientation to place (5 points); Registration of three words (3 points); Attention and Calculation (5 points); Recall of three words (3 points); Language (8 points) and Visual Construction (1 point). The severity of cognitive impairment is classified as normal (30-27) mild cognitive impairment (26-20); moderate cognitive impairment (19-10); and severe cognitive impairment(< 10).	First day
Secondary	Functional exercise capacity	6 minute walking test	Second day