NCT05242380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

December 25, 2021

Last Update Submit

October 26, 2023

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (4)

  • 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

  • Functional capacity

    The 6-minute walk test will be performed.

    8 weeks

  • 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

  • Handgrip strength

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

    8 weeks

Secondary Outcomes (4)

  • Activity status

    8 weeks

  • Health-related quality of life

    8 weeks

  • Activities of daily living

    8 weeks

  • Sleep quality

    8 weeks

Study Arms (2)

Kettlebell Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Kettlebell Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

Location

Related 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.

    PMID: 30243898BACKGROUND

  • 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.

    PMID: 21210281BACKGROUND

  • 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.

    PMID: 33201750BACKGROUND

  • 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.

    PMID: 16982941BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rengin Demir, PhD, PT

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 25, 2021

First Posted

February 16, 2022

Study Start

June 10, 2022

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

TU(1)