Effects of Upper Extremity Aerobic Exercise Training in Patients With Interstitial Lung Disease

NCT05916404 | Unknown

• 1 other identifier: Gazi University-58
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Severe dyspnea, cough, fatigue, restrictive type ventilation disorder, decreased pulmonary function, impaired gas exchange, decreased cardiovascular function and exercise intolerance are frequently encountered findings in patients with interstitial lung disease. It was demonstrated exercise training has beneficial effects in patients with interstitial lung disease. However, no study investigated the effects of upper extremity aerobic exercise training on outcomes in patients with interstitial lung disease.

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease; Upper Extremity; Aerobic Exercise; Oxygen Consumption; Physical Activity

Outcome Measures

Primary Outcomes (3)

• Oxygen consumption

  Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.

  through study completion, an average of 2 year

• Muscle oxygenation

  Before the cardiopulmonary exercise test and the 6-minute pegboard and ring test (6-PBRT), during and after the tests the muscle oxygenation will be measured by using a near-infrared spectroscopy device. Oxygenation of the quadriceps muscle during the cardiopulmonary exercise test, and deltoid muscle during the 6-PBRT will be evaluated. For this purpose, the sensor will be placed at the midpoint of the dominant side muscles.

  through study completion, an average of 2 year

• Physical activity level

  Physical activity level will be evaluated with a multi-sensor activity device. Multisensor metabolic holter device by detecting the three-dimensional movements of patients; It provides data on total energy expenditure (joules/day), active energy expenditure (joules/day), physical activity duration (min/day), average MET (MET/day), number of steps (steps/day), time spent lying down (min/day). The device will be attached to the non-dominant arms of the patients, and they will be told to wear it for 5 consecutive days, remove the device only during the bath, and reinsert it in the same area after the bath. The average of the parameters of the current four days will be taken and analyzed with the "BodyMedia SenseWear® 7.0 Software" program using the age, gender, body weight and height information of the patients.

  through study completion, an average of 2 year

Secondary Outcomes (19)

• Respiratory muscle strength

  through study completion, an average of 2 year

• Peripheral muscle strength

  through study completion, an average of 2 year

• Upper extremity functional exercise capacity

  through study completion, an average of 2 year

• Dyspnea perception

  through study completion, an average of 2 year

• Fatigue

  through study completion, an average of 2 year

Study Arms (2)

Training Group

EXPERIMENTAL

The training group will receive upper extremity high-intensity interval aerobic exercise training on an arm ergometer accompanied by a physiotherapist for 6 weeks.

Other: Upper extremity high-intensity interval aerobic exercise training

Control Group

SHAM COMPARATOR

The control group will not be given any training for 6 weeks during the study period.

Other: Control Group

Interventions

Upper extremity high-intensity interval aerobic exercise training OTHER

High-intensity interval aerobic exercise training will be given to the training group on an arm ergometer 3 days in a week and 30-45 minutes a day for 6 weeks with the assistance of a physiotherapist. The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate. The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate. In case of desaturation (\<90%) during the training in the patients in the training group, O2 support with a nasal cannula will be given to the patient.

Training Group

Control Group OTHER

The control group will not be given any training during the 6-week period. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with ILD according to ATS/ERS criteria,
• Aged between 18-75 years,
• No pulmonary infection during the last month,
• Patients who volunteer to participate in the study

You may not qualify if:

• Patients with,
• Body mass index \>35 kg/m2,
• An acute pulmonary exacerbation within the last 4 weeks, have an acute upper or lower respiratory tract infection,
• Presence of obstructive pulmonary disease,
• Serious neurological, neuromuscular, orthopedic, or other diseases affecting physical functions,
• Participated in a planned exercise program within the last three months,
• Cognitive impairment that causes them to have difficulty understanding and following exercise test instructions,
• Contraindications for exercise testing and/or exercise training according to the American College of Sports Medicine
• Cancer, renal or hepatic diseases,
• Aortic stenosis, complex arrhythmia, with aortic aneurysm,
• Uncontrolled hypertension, diabetes mellitus, heart failure, arrhythmia and serious cardiovascular disease

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nazire Nur YILDIZ, M.Sc.

  Gazi University

  STUDY CHAIR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

• Riad BEJTA, Pt.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nilgün YILMAZ DEMİRCİ, Assoc. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Nazire Nur YILDIZ, M.Sc.

CONTACT

+905444184376; nnuryildiz58@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times. Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: June 23, 2023
• Study Start: July 3, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)