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Completed

NCT Number: NCT05242380

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Kettlebell exercise

Other

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.

Primary outcomes

  1. Task related oxygen uptake

    Time frame: 8 weeks

    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.

  2. Functional capacity

    Time frame: 8 weeks

    The 6-minute walk test will be performed.

  3. Peripheral muscle strength

    Time frame: 8 weeks

    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.

  4. Handgrip strength

    Time frame: 8 weeks

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

Secondary outcomes

  1. Activity status

    Time frame: 8 weeks

    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.

  2. Health-related quality of life

    Time frame: 8 weeks

    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.

  3. Activities of daily living

    Time frame: 8 weeks

    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

  4. Sleep quality

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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