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Pulmonary Arterial HypertensionNCT05242380

Exercise Training in Patients With Pulmonary Arterial Hypertension

A study testing Kettlebell Exercise in people with Pulmonary Arterial Hypertension, run by Saglik Bilimleri Universitesi 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

In this study, the effects of kettlebell exercise training on functional capacity, dyspnea and activities of daily living in patients diagnosed with Pulmonary Arterial Hypertension (PAH) will be investigated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Kettlebell Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jun 2022to 15 Sep 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with pulmonary arterial hypertension (PAH) by a specialist physician in accordance with the 2015 guideline for the treatment and diagnosis of pulmonary hypertension of the European Heart and Respiratory Societies (ERS/ESC),
  • Patients with stable pharmacological treatment,
  • Patients clinically stable at least last three months.

Who cannot join

  • Presence of orthopedic or neurological problems that will affect functional tests and muscle strength measurement,
  • Recent surgical procedures,
  • Recent syncope,
  • Pregnancy,
  • Presence of severe left heart failure,
  • Presence of severe ischemic heart disease,
  • Hypertensive patients,
  • Patients who have problems in communicating.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University - Cerrahpasa, Institute of Cardiology

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Kettlebell Exercise Training in Patients With Pulmonary Arterial Hypertension

In this study, the effects of kettlebell exercise training on functional capacity, dyspnea and activities of daily living in patients diagnosed with Pulmonary Arterial Hypertension (PAH) will be investigated.

Being tested
Kettlebell Exercise
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

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

  • Kettlebell ExerciseOther

    The exercise training plan for this group consists of 4 stages. Each stage lasts 2 weeks and consist of 5 kettlebell (KB) exercises. These exercises will continue from basic (single movement training) to advanced (comprehensive movement training) and is geared towards functional training. Participants will perform 2 sets of 12 repetitions of each exercise. Each training session is planned to last 45 minutes.

    The following exercises will be used in KB training: biceps curl, triceps extension, kettlebell swing (two-handed), kettlebell dead lift, kettlebell goblet squat, suitcase carry, waiter carry, bottoms up carry, farmer's walk, overhead carry, lunge, kettlebell row.

Study groups in NCT05242380
Study groupRoleWhat they receive
Kettlebell ExerciseExperimental8-week, 3-day/week supervised training will be applied to the participants in this group. After the initial assessment, patients in this group will receive a one-session education on the pathophysiology of PAH, the benefits of physical activity, and energy conservation techniques during activities of daily living. Pharmacological treatment of patients in this group will be continued.
Receives: Other: Kettlebell Exercise
ControlNo interventionAny intervention will not be performed. After the initial assessment, patients in this group will receive a one-session education on the pathophysiology of PAH, the benefits of physical activity, and energy conservation techniques during activities of daily living. Pharmacological treatment of patients in this group will be continued.

What is being measured

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

  1. Task related oxygen uptake

    Cardiopulmonary data will be evaluated with mobile cardiopulmonary exercise test during daily activities. Participants will perform the following activities with mobile cardiopulmonary exercise test (CPET): putting on socks on both feet (sitting on a chair), putting on both shoes (sitting on a chair), putting on a coat (while standing), lifting material (placing 6 jars -each 400 gram- at chest-level height), sweeping the floor for 4 minutes, washing dishes for 4 minutes, go up and down stairs - 1 floor. There will be a 5 minute rest between all activities.

    Measured: 8 weeks

  2. Functional capacity

    The 6-minute walk test will be performed.

    Measured: 8 weeks

  3. Peripheral muscle strength

    Isometric muscle strength will be measured with a handheld dynamometer for elbow flexion, knee extension, knee flexion, shoulder flexion, shoulder abduction, hip flexion and m.serratus anterior.

    Measured: 8 weeks

  4. Handgrip strength

    Hand grip strength will be measured with a digital hand dynamometer.

    Measured: 8 weeks

Secondary outcomes (4)

  1. Activity status

    This outcome will be assessed with the Duke Activity Status Index. As a result of scoring, a total score ranging from 0 to 58.2 is obtained. Higher scores indicate higher functional capacity.

    Measured: 8 weeks

  2. Health-related quality of life

    This outcome will be assessed with the emPHasis-10. emPHasis-10 consists of 10 items and results in a score out of 50, where a higher score represents a higher symptom burden.

    Measured: 8 weeks

  3. Activities of daily living

    This outcome will be assessed with the London Chest Activity of Daily Living Scale. It is a questionnaire consisting of fifteen items. Each item is given a score ranging from 0 to 5. Higher scores indicate greater limitation in activities of daily living. The total score can reach a maximum of 75

    Measured: 8 weeks

  4. Sleep quality

    This outcome will be assessed with the Pittsburgh Sleep Quality Index. The questionnaire consists of 19 individual items. Each item is given a score ranging from 0 to 3, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

    Measured: 8 weeks

Timeline

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

  1. First posted16 Feb 2022
  2. Study start10 Jun 2022
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242380
Sponsor's protocol ID
2021-152558
Status last verified
Oct 2023
First submitted
25 Dec 2021
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen HT, Wu HJ, Chen YJ, Ho SY, Chung YC. Effects of 8-week kettlebell training on body composition, muscle strength, pulmonary function, and chronic low-grade inflammation in elderly women with sarcopenia. Exp Gerontol. 2018 Oct 2;112:112-118. doi: 10.1016/j.exger.2018.09.015. Epub 2018 Sep 20.

    PubMed 30243898

  • Spruit MA, Wouters EF, Eterman RM, Meijer K, Wagers SS, Stakenborg KH, Uszko-Lencer NH. Task-related oxygen uptake and symptoms during activities of daily life in CHF patients and healthy subjects. Eur J Appl Physiol. 2011 Aug;111(8):1679-86. doi: 10.1007/s00421-010-1794-y. Epub 2011 Jan 6.

    PubMed 21210281

  • Mapelli M, Salvioni E, Bonomi A, Gugliandolo P, De Martino F, Vignati C, Berna G, Agostoni P. How Patients With Heart Failure Perform Daily Life Activities: An Innate Energy-Saving Strategy. Circ Heart Fail. 2020 Nov;13(11):e007503. doi: 10.1161/CIRCHEARTFAILURE.120.007503. Epub 2020 Nov 17.

    PubMed 33201750

  • Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.

    PubMed 16982941

  • Merc P, Demi̇r R, Zeren M, Si̇nan UY, Deni̇z MF, Engi̇n K, Kucukoglu MS. Effects of kettlebell exercise training on functional capacity and metabolic costs of activities of daily living in patients with pulmonary arterial hypertension: A randomized controlled trial. Respir Med. 2025 Nov;248:108371. doi: 10.1016/j.rmed.2025.108371. Epub 2025 Sep 24.

    PubMed 41005681

Questions about this trial

What is this clinical trial studying?

A study testing Kettlebell Exercise in people with Pulmonary Arterial Hypertension, run by Saglik Bilimleri Universitesi 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 8 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 27 Oct 2023. 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?

Task related oxygen uptake (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 NCT05242380, 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 27 Oct 2023.

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