Exercise Training in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242380
• Other study ID #: 2021-152558
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: October 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa, Institute of Cardiology	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	Functional capacity	The 6-minute walk test will be performed.	8 weeks
Primary	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.	8 weeks
Primary	Handgrip strength	Hand grip strength will be measured with a digital hand dynamometer.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks
Secondary	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.	8 weeks