Exercise Training in Patients With Pulmonary Arterial Hypertension

October 26, 2023 updated by: Pinar BASTURK, Saglik Bilimleri Universitesi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University - Cerrahpasa, Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kettlebell Exercise
8-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.
Other: Kettlebell Exercise

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.
No Intervention: Control
Any 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
Functional capacity
Time Frame: 8 weeks
The 6-minute walk test will be performed.
8 weeks
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.
8 weeks
Handgrip strength
Time Frame: 8 weeks
Hand grip strength will be measured with a digital hand dynamometer.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Collaborators

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Rengin Demir, PhD, PT, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

December 25, 2021

First Submitted That Met QC Criteria

February 6, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-152558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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