Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker
- Conditions
- Pacemaker
- Interventions
- Device: Inspiratory muscle endurance trainingDevice: Inspiratory muscle strength training
- Registration Number
- NCT03501355
- Lead Sponsor
- Gazi University
- Brief 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
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Heart failure patients with Pacemaker who are clinically stable
- After 12 weeks of pacemaker implantation
- No change in medications over one month
Patients with
- Severe cognitive disorders
- Pulmonary, neurological and orthopedic diseases
- Pregnant and lactating patients
- Acute infection or exacerbation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endurance training group Inspiratory muscle endurance training Intervention: Inspiratory muscle endurance training group received inspiratory muscle endurance training (IMT) using POWERbreathe Classic threshold loading device Strength training group Inspiratory muscle strength training Intervention:Inspiratory muscle strength training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
- Primary Outcome Measures
Name Time Method Maximal Exercise capacity First day Incremental Shuttle Walk Test
- Secondary Outcome Measures
Name Time Method Depression Second day 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.
Inspiratory and expiratory muscle strength (MIP, MEP) First day Mouth pressure device
Pulmonary functions First day Spirometry
Peripheral muscle strength First day Hand held dynamometer
Fatigue Second day 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
Quality of life Second day 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).
Health-related quality of life Second day 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).
Functional exercise capacity Second day 6 minute walking test
Physical activity Second day 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.
Cognitive function First day 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).
Trial Locations
- Locations (1)
Mustafa Kemal University
🇹🇷Hatay, Turkey