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Exercise Training in Patients With Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kettlebell Exercise
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul University - Cerrahpasa, Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kettlebell Exercise

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Functional capacity
The 6-minute walk test will be performed.
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.
Handgrip strength
Hand grip strength will be measured with a digital hand dynamometer.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
December 25, 2021
Last Updated
May 4, 2023
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05242380
Brief Title
Exercise Training in Patients With Pulmonary Arterial Hypertension
Official Title
The Effects of Kettlebell Exercise Training in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kettlebell Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Kettlebell Exercise
Intervention Description
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 Outcome Measure Information:
Title
Task related oxygen uptake
Description
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.
Time Frame
8 weeks
Title
Functional capacity
Description
The 6-minute walk test will be performed.
Time Frame
8 weeks
Title
Peripheral muscle strength
Description
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.
Time Frame
8 weeks
Title
Handgrip strength
Description
Hand grip strength will be measured with a digital hand dynamometer.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Activity status
Description
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.
Time Frame
8 weeks
Title
Health-related quality of life
Description
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.
Time Frame
8 weeks
Title
Activities of daily living
Description
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
Time Frame
8 weeks
Title
Sleep quality
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pınar Baştürk, MSc
Phone
+90(216)4189616
Ext
2619
Email
pinarrbasturk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rengin Demir, PhD, PT
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University - Cerrahpasa, Institute of Cardiology
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Serdar Küçükoğlu, PhD, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30243898
Citation
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.
Results Reference
background
PubMed Identifier
21210281
Citation
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.
Results Reference
background
PubMed Identifier
33201750
Citation
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.
Results Reference
background
PubMed Identifier
16982941
Citation
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.
Results Reference
background

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Exercise Training in Patients With Pulmonary Arterial Hypertension

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