The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis

NCT04173689 | Completed

• 1 other identifier: Pulmonary Sarcoidosis
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an educational work. Thirty patients with pulmonary sarcoidosis will be included in the study and randomly selected into two training groups.One group will receive home inspiratory muscle training (IMT) for 15 minutes, twice a day, 7 days a week with the resh Threshold IMT 'device. In the IMT group, the initial training intensity will be determined by measuring the maximal inspiratory muscle strength (MIP) with the intraoral pressure measuring device, 30% of the measured (MIP) value will be started at the first evaluation and the new training intensity will be determined by calculating 30% of the measured value by repeating the MIP measurement every week. The other group will perform upper extremity and trunk exercises combined with respiratory exercises at home for 7 days, twice a day for 15 minutes.Patients will be evaluated before the training program and 8 weeks after the training. In the first evaluation, demographic information and clinical characteristics of the patients will be noted.In this study, upper and lower extremity exercise capacity, respiratory functions, peripheral muscle strength, dyspnea, fatigue, sleep quality, cognitive function, daily living activities, physical activity level, anxiety, depression, upper extremity and trunk exercises combined with inspiratory muscle training in patients with sarcoidosis and the impact on quality of life.

Conditions

Pulmonary Sarcoidosis

Keywords

Sarcoidosis

Outcome Measures

Primary Outcomes (9)

• Fatigue severity scale

  0-7. high score shows deterioration. \<2,8 no fatigue. \>6,1 chronic fatigue syndrome

  8 week

• 6 minute walk test

  Increased walking distance in 6 minutes

  8 week

• Medical Research Council Dyspnea Scale

  0-4. high score shows deterioration

  8 week

• Respiratory assesment

  measure respiratory muscle strength

  8 week

• Epworth sleepiness scale

  0-30. high score shows deterioration

  8 week

• Hospital Anxiety Scale

  anxiety 0-21 .high score shows deterioration

  8 week

• Hospital Depression Scale

  depression 0-21. high score shows deterioration

  8 week

• Montreal Cognitive Assessment Scale

  assess cognitive functions of individuals.0-30. high score indicates improvement

  8 week

• London Chest Daily Living Activities Scale

  Measuring daily living activities. high score shows deterioration. 0-75

  8 week

Study Arms (2)

Inspiratuar muscle training group

ACTIVE COMPARATOR

This group will be given inspiratory muscle training (IMT) at home for 15 minutes twice a day for 7 days a week with the resh Threshold IMT 'device. In the IMT group, the initial training intensity will be determined by measuring the maximal inspiratory muscle strength (MRP) with the intraoral pressure measuring device, 30% of the measured MRP value will be started at the first evaluation and the new training intensity will be determined by calculating 30% of the measured value by repeating the MRP measurement every week.

Device: Threshold IMT

Exercise group

ACTIVE COMPARATOR

This group will perform upper extremity and trunk exercises combined with breathing exercises at home for 7 days, twice a day for 15 minutes. Patients in both groups will perform a single 15-minute session once a week at the hospital under the supervision of a physiotherapist.

Other: breathing exercises combined with upper extremity and trunk

Interventions

Threshold IMT DEVICE

7 days a week, 2 times a day 15 min each

Also known as: Philips

Inspiratuar muscle training group

breathing exercises combined with upper extremity and trunk OTHER

upper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each

Exercise group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study was conducted in Istanbul University Cerrahpaşa Medical Faculty Hospital Pulmonary Diseases Department with sarcoidosis diagnosed with pulmonary involvement in stage II-III,
• months after receiving systemic treatment or no treatment.

You may not qualify if:

• Patients with stage I and IV,
• malignancy,
• heart failure,
• orthopedic problems
• who had to undergo systemic sarcoidosis treatment during the study

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Esma Yıldız

Edirne, Istanbul, 22000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Sarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Rengin DEMİR

  counselor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 22, 2019
• Study Start: January 15, 2020
• Primary Completion: April 29, 2021
• Study Completion: June 30, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)