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PacemakerNCT03501355

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

A study testing Inspiratory muscle strength training and Inspiratory muscle endurance training in people with Pacemaker, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pacemaker
What is being tested?
Inspiratory muscle strength training and Inspiratory muscle endurance training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2018to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Heart failure patients with Pacemaker who are clinically stable
  • After 12 weeks of pacemaker implantation
  • No change in medications over one month

Who cannot join

  • Patients with
  • Severe cognitive disorders
  • Pulmonary, neurological and orthopedic diseases
  • Pregnant and lactating patients
  • Acute infection or exacerbation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Mustafa Kemal University

    Hatay, 31135

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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.

Conditions
Pacemaker
Being tested
Inspiratory muscle strength training, Inspiratory muscle endurance training
Keywords
pacemaker, inspiratory muscle training, exercise capacity, Quality of Life, Respiratory Muscle Strength

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory muscle strength trainingDevice

    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 trainingDevice

    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.

Study groups in NCT03501355
Study groupRoleWhat they receive
Strength training groupActive comparatorIntervention:Inspiratory muscle strength training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Receives: Device: Inspiratory muscle strength training
Endurance training groupActive comparatorIntervention: Inspiratory muscle endurance training group received inspiratory muscle endurance training (IMT) using POWERbreathe Classic threshold loading device
Receives: Device: Inspiratory muscle endurance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Exercise capacity

    Incremental Shuttle Walk Test

    Measured: First day

Secondary outcomes (10)

  1. Inspiratory and expiratory muscle strength (MIP, MEP)

    Mouth pressure device

    Measured: First day

  2. Peripheral muscle strength

    Hand held dynamometer

    Measured: First day

  3. Pulmonary functions

    Spirometry

    Measured: First day

  4. 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

    Measured: Second day

  5. 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).

    Measured: Second day

  6. 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.

    Measured: Second day

  7. 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.

    Measured: Second day

  8. 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).

    Measured: Second day

  9. 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).

    Measured: First day

  10. Functional exercise capacity

    6 minute walking test

    Measured: Second day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start20 Apr 2018
  3. Primary completion30 May 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03501355
Sponsor's protocol ID
Gazi University 7
Status last verified
Jul 2021
First submitted
10 Apr 2018
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29465496

  • 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. doi: 10.1097/01.hjr.0000230104.93771.7d.

    PubMed 17001224

  • 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.

    PubMed 25792557

  • 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.

    PubMed 26667151

  • Katayifci N, Bosnak Guclu M, Sen F. A comparison of the effects of inspiratory muscle strength and endurance training on exercise capacity, respiratory muscle strength and endurance, and quality of life in pacemaker patients with heart failure: A randomized study. Heart Lung. 2022 Sep-Oct;55:49-58. doi: 10.1016/j.hrtlng.2022.04.006. Epub 2022 Apr 23.

    PubMed 35472660

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory muscle strength training and Inspiratory muscle endurance training in people with Pacemaker, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Exercise capacity (time frame: First day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03501355, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

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