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

Primary Purpose

Pulmonary Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Threshold IMT
breathing exercises combined with upper extremity and trunk
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Sarcoidosis focused on measuring Sarcoidosis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Esma Yıldız

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inspiratuar muscle training group

Exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fatigue severity scale
0-7. high score shows deterioration. <2,8 no fatigue. >6,1 chronic fatigue syndrome
6 minute walk test
Increased walking distance in 6 minutes
Medical Research Council Dyspnea Scale
0-4. high score shows deterioration
Respiratory assesment
measure respiratory muscle strength
Epworth sleepiness scale
0-30. high score shows deterioration
Hospital Anxiety Scale
anxiety 0-21 .high score shows deterioration
Hospital Depression Scale
depression 0-21. high score shows deterioration
Montreal Cognitive Assessment Scale
assess cognitive functions of individuals.0-30. high score indicates improvement
London Chest Daily Living Activities Scale
Measuring daily living activities. high score shows deterioration. 0-75

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
May 26, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04173689
Brief Title
The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
Acronym
physio
Official Title
The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients who are in stage II-III with sarcoidosis diagnosed pulmonary involvement who are admitted to the Department of Chest Diseases of Cerrahpaşa Medical Faculty Hospital of Istanbul University will be included in the 30-70 age group 6 months after systemic treatment or no treatment. Patients with stages I and IV, malignancy, heart failure, orthopedic problems and who have to undergo systemic sarcoidosis treatment during the study will not be included in the study. Thirty-four patients who meet the inclusion criteria will be included in the study by signing the informed consent form. In the first evaluation, demographic information and clinical characteristics of the patients will be noted. Lower and upper extremity functional capacities of the patients before and after training will be evaluated with 6-minute walk test (6MWT), 6-minute step test (6DST), 6-minute pegboard ring test (6DPBRT) and 30-second sit-down test. Percentage values of FVC, FEV1, FEV1 / FVC, PEF, FEF (25-75%) parameters according to measured and expected values will be recorded by performing pulmonary function test. Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MRP) and maximal expiratory pressure (MEP) with the intraoral pressure gauge. Dyspnea sensation Modified Borg and Modified Medical Research Council (MMRC) scale, fatigue state Fatigue Severity Scale (FSS), peripheral muscle strength hand dynamometer, quality of life George Respiratory Diseases Questionnaire (SGRQ), anxiety and depression status Hospital Anxiety and Depression Scale (HAD), physical activity level International Physical Activity Questionnaire-Short form (IPAQ-S), cognitive function Montreal Cognitive Assessment Scale (MOCA), daily living activities London Chest Daily Living Activities Scale and sleep quality will be evaluated with Epworth Sleepiness Scale (ESS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Sarcoidosis
Keywords
Sarcoidosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratuar muscle training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Threshold IMT
Other Intervention Name(s)
Philips
Intervention Description
7 days a week, 2 times a day 15 min each
Intervention Type
Other
Intervention Name(s)
breathing exercises combined with upper extremity and trunk
Intervention Description
upper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each
Primary Outcome Measure Information:
Title
Fatigue severity scale
Description
0-7. high score shows deterioration. <2,8 no fatigue. >6,1 chronic fatigue syndrome
Time Frame
8 week
Title
6 minute walk test
Description
Increased walking distance in 6 minutes
Time Frame
8 week
Title
Medical Research Council Dyspnea Scale
Description
0-4. high score shows deterioration
Time Frame
8 week
Title
Respiratory assesment
Description
measure respiratory muscle strength
Time Frame
8 week
Title
Epworth sleepiness scale
Description
0-30. high score shows deterioration
Time Frame
8 week
Title
Hospital Anxiety Scale
Description
anxiety 0-21 .high score shows deterioration
Time Frame
8 week
Title
Hospital Depression Scale
Description
depression 0-21. high score shows deterioration
Time Frame
8 week
Title
Montreal Cognitive Assessment Scale
Description
assess cognitive functions of individuals.0-30. high score indicates improvement
Time Frame
8 week
Title
London Chest Daily Living Activities Scale
Description
Measuring daily living activities. high score shows deterioration. 0-75
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study was conducted in Istanbul University Cerrahpaşa Medical Faculty Hospital Pulmonary Diseases Department with sarcoidosis diagnosed with pulmonary involvement in stage II-III, 6 months after receiving systemic treatment or no treatment. Exclusion Criteria: Patients with stage I and IV, malignancy, heart failure, orthopedic problems who had to undergo systemic sarcoidosis treatment during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rengin DEMİR
Organizational Affiliation
counselor
Official's Role
Study Director
Facility Information:
Facility Name
Esma Yıldız
City
Edirne
State/Province
Istanbul
ZIP/Postal Code
22000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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