An interventional study of Inspiratory muscle strength training and Inspiratory muscle endurance training in Pacemaker, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by Gazi University · Not applicable, Interventional, and Supportive care
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
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 30 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with
Intervention:Inspiratory muscle strength training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Device: Inspiratory muscle strength training
Intervention: Inspiratory muscle endurance training group received inspiratory muscle endurance training (IMT) using POWERbreathe Classic threshold loading device
Device: Inspiratory muscle endurance 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.
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.
Maximal Exercise capacity
Incremental Shuttle Walk Test
Time frame: First day
Inspiratory and expiratory muscle strength (MIP, MEP)
Mouth pressure device
Time frame: First day
Peripheral muscle strength
Hand held dynamometer
Time frame: First day
Pulmonary functions
Spirometry
Time frame: First day
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
Time frame: Second day
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).
Time frame: Second day
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.
Time frame: Second day
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.
Time frame: Second day
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).
Time frame: Second day
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).
Time frame: First day
Functional exercise capacity
6 minute walking test
Time frame: Second day
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gazi University