NCT05947240

Brief Summary

Group A will be training group and group B will be control group. Deep breathing exercises will be done as baseline treatment in both groups. Both groups will be assessed with Modified Borg scale, 6-PBRT and Fatigue severity scale at the baseline. The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute. Intervention will be for 3 times a week or 6 weeks. The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist. Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min, 3 times/week over 6 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

June 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 14, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Upper Extremity Aerobic Exercise Training;; Exercise Capacity; Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 6 MWT

    The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).The self-paced 6MWT assesses the submaximal level of functional capacity.

    4 weeks

  • Borg rating of perceived exertion (RPE)

    Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is used in monitoring progress and mode of exercise in cardiac patients as well as in other patient populations undergoing rehabilitation and endurance training.Borg RPE scale was developed by Gunnar Borg for rating exertion and breathlessness during physical activity ; that is, how hard the activity is as shown by high heart and respiration rate , profuse perspiration and muscle exertion.

    4 weeks

Study Arms (2)

upper extremity aerobic exercises

EXPERIMENTAL

The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist. Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min,3 times/week over 6 weeks.

Other: aerobic exercises

active alternating movements for the upper limbs a

EXPERIMENTAL

The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute. Intervention will be for 3 times a week or 6 weeks.

Other: active alternating movements for the upper limbs

Interventions

The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist.

upper extremity aerobic exercises

The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute. Intervention will be for 3 times a week or 6 weeks.

active alternating movements for the upper limbs a

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient diagnosed with pulmonary arterial hypertension.
  • Both the sex was considered.
  • Age range from 35 to 60 years.
  • Patients who were stable.
  • Patient under optimal medical therapy for at least three months before participating in this study
  • Willing to participate in study (13).

You may not qualify if:

  • Patient with cognitive disorders.
  • Patient with orthopedic or neurological diseases. acute infection or pneumonia
  • Patient with class IV heart failure.
  • Patient with acute infection or pneumonia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National hospital and Ittefaq hospital in Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (6)

  • Malenfant S, Lebret M, Breton-Gagnon E, Potus F, Paulin R, Bonnet S, Provencher S. Exercise intolerance in pulmonary arterial hypertension: insight into central and peripheral pathophysiological mechanisms. Eur Respir Rev. 2021 Apr 13;30(160):200284. doi: 10.1183/16000617.0284-2020. Print 2021 Jun 30.

    PMID: 33853885BACKGROUND
  • Karapolat H, Cinar ME, Tanigor G, Nalbantgil S, Kayikcioglu M, Mogulkoc N, Kultursay H. Effects of cardiopulmonary rehabilitation on pulmonary arterial hypertension: A prospective, randomized study. Turk J Phys Med Rehabil. 2019 May 8;65(3):278-286. doi: 10.5606/tftrd.2019.2758. eCollection 2019 Sep.

    PMID: 31663077BACKGROUND
  • Cedeno de Jesus S, Almadana Pacheco V, Valido Morales A, Muniz Rodriguez AM, Ayerbe Garcia R, Arnedillo-Munoz A. Exercise Capacity and Physical Activity in Non-Cystic Fibrosis Bronchiectasis after a Pulmonary Rehabilitation Home-Based Programme: A Randomised Controlled Trial. Int J Environ Res Public Health. 2022 Sep 3;19(17):11039. doi: 10.3390/ijerph191711039.

    PMID: 36078768BACKGROUND
  • Waller L, Kruger K, Conrad K, Weiss A, Alack K. Effects of Different Types of Exercise Training on Pulmonary Arterial Hypertension: A Systematic Review. J Clin Med. 2020 Jun 2;9(6):1689. doi: 10.3390/jcm9061689.

    PMID: 32498263BACKGROUND
  • McCormack C, Kehoe B, Hardcastle SJ, McCaffrey N, McCarren A, Gaine S, McCullagh B, Moyna N. Pulmonary hypertension and home-based (PHAHB) exercise intervention: protocol for a feasibility study. BMJ Open. 2021 May 10;11(5):e045460. doi: 10.1136/bmjopen-2020-045460.

    PMID: 33972341BACKGROUND
  • Zeng X, Chen H, Ruan H, Ye X, Li J, Hong C. Effectiveness and safety of exercise training and rehabilitation in pulmonary hypertension: a systematic review and meta-analysis. J Thorac Dis. 2020 May;12(5):2691-2705. doi: 10.21037/jtd.2020.03.69.

    PMID: 32642177BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sidra Faisal, MS.CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A will be training group and group B will be control group. Deep breathing exercises will be done as baseline treatment in both groups. Both groups will be assessed with Modified Borg scale, 6-PBRT and Fatigue severity scale at the baseline. The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute. Intervention will be for 3 times a week or 6 weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 17, 2023

Study Start

June 15, 2023

Primary Completion

September 10, 2023

Study Completion

December 15, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations