NCT06471439

Brief Summary

COPD presents not only respiratory symtoms but also vascular or muscle dysfunction. Exercise limitation is observed in COPD. Especially, decreased exercise performance related to vascular and fatique in quadriceps muscle. Exercise training is important for aerobic performance increasing. Generally results show exercise training with both lower limb. Increaed arterial stiffness and fatigue are observed in COPD. One leg exercise training result is not enough to highlight these parameters. Three types single leg exercise intervantion will be applied. Exercise capacity, muscle strength, lung function, electromyography, lactate and quality of life will be measured.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

June 16, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

May 17, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseSingle Limb exerciseresistance trainingcontinous exercise traininghigh intensity exercise training

Outcome Measures

Primary Outcomes (1)

  • six minute walk test

    six minute walk test in meter

    pre-intervention

Secondary Outcomes (9)

  • cardiopulmonary exercise test

    beginning day 2

  • one leg cardiopulmonary exercise test

    beginning, day 3

  • quadriceps muscle strength assesing (repeated measeure)

    beginning day 1 and last day

  • isometrics quadriceps muscle strength assesing

    beginning day 1 and last day

  • lung function

    beginning day 1 and last day

  • +4 more secondary outcomes

Study Arms (3)

single leg resistance exercise intervantion in COPD

ACTIVE COMPARATOR

single leg resistance exercise intervantion in COPD will be perfomed at six weeks

Other: single leg exercise intervantion in COPD

single leg continous exercise intervantion in COPD

ACTIVE COMPARATOR

single leg continous exercise intervantion in COPD will be perfomed at six weeks

Other: single leg exercise intervantion in COPD

single leg high intensity exercise intervantion in COPD

ACTIVE COMPARATOR

single leg high intensity exercise intervantion in COPD will be perfomed at six weeks

Other: single leg exercise intervantion in COPD

Interventions

single leg exercise intervantions 1. high intensity interval training 2. continous exercise training 3. resistance exercise training

Also known as: single leg exercise intervantion
single leg continous exercise intervantion in COPDsingle leg high intensity exercise intervantion in COPDsingle leg resistance exercise intervantion in COPD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients that applied to physiotherapy
  • Cooperation for tests
  • without severe ortopedical and neurological disease
  • without severe cardiovascular disease
  • To volunteer for the study.

You may not qualify if:

  • have an acute exacerbation or having exacerbation at last month
  • hypoxemia (PaO2\<55mmHg)
  • no cooperated to test without volunteer to study having ortophedical and neurological diesase that affecting of tests severe cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Kocaaga

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Dolmage TE, Goldstein RS. Effects of one-legged exercise training of patients with COPD. Chest. 2008 Feb;133(2):370-6. doi: 10.1378/chest.07-1423. Epub 2007 Oct 9.

    PMID: 17925417BACKGROUND
  • Evans RA, Dolmage TE, Mangovski-Alzamora S, Romano J, O'Brien L, Brooks D, Goldstein RS. One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. Ann Am Thorac Soc. 2015 Oct;12(10):1490-7. doi: 10.1513/AnnalsATS.201504-231OC.

    PMID: 26291542BACKGROUND
  • MacInnis MJ, Morris N, Sonne MW, Zuniga AF, Keir PJ, Potvin JR, Gibala MJ. Physiological responses to incremental, interval, and continuous counterweighted single-leg and double-leg cycling at the same relative intensities. Eur J Appl Physiol. 2017 Jul;117(7):1423-1435. doi: 10.1007/s00421-017-3635-8. Epub 2017 May 11.

    PMID: 28497384BACKGROUND

MeSH Terms

Conditions

Motor ActivityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

BehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • elif kocaaga, ms

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: three different type one leg exercise intervention are apllied in patients with copd
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 17, 2024

First Posted

June 24, 2024

Study Start

June 16, 2023

Primary Completion

January 2, 2025

Study Completion

January 2, 2025

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations