Chair-based and Standard Exercise Programs in People With COPD

COPD Clinical Trial

Official title:

Comparison of the Effectiveness of Chair-based and Standard Exercise Programs in People With COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201299
• Other study ID #: COPD_Chair exercises
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Istanbul Medipol University Hospital
• Contact: ESRA PEHLIVAN
• Phone: 09050585279
• Email: fztesrakambur[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients who are diagnosed with COPD by a pulmonology specialist and referred to pulmonary rehabilitation will be included in the study. Cases that meet the inclusion criteria will be randomized and divided into two groups, standard exercise program group (SGr) and chair-based exercise. program group will be called (ChGr). While standard exercises will be given to SGr, chair-based exercises will be applied to ChGr. All evaluation and initial training sessions of the cases will be held in the hospital. Apart from this, they will be asked to do their exercises at home with the exercise videos that will be sent to them. In order to ensure that home exercises are performed completely and correctly, 2 sessions of online simultaneous exercise training will be provided with a physiotherapist via videoconference on a smartphone, and exercise follow-ups will be carried out by calling once a week. The program duration is 8 weeks, 5 days a week.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-75 years
• Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
• Presence of dyspnea on exertion
• Stable clinical status at inclusion without infection or exacerbation in the previous 4 weeks *Having smart phone usage skills

Exclusion Criteria:

• Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (? 3-4 L\min).
• A history of exertional syncope or the presence of any comorbidities (such as severe orthopedic or neurological deficits or unstable heart disease) that preclude exercise training.
• Having participated in a pulmonary rehabilitation program within the last 12 months.

Related Conditions & MeSH terms

• COPD
• Exercise
• Pulmonary Rehabilitation

Intervention

Other:
• Standard Exercise Program
The program content consists of breathing exercises, upper and lower extremity strengthening with theraband and self-walking. Chest, abdominal and lateral basal breathing exercises will be performed 10 times each. Resistance exercises will be performed as strengthening exercises for the major muscle groups of the upper and lower extremities using medium-hard theraband. Patients will be asked to walk 30 minutes a day on flat ground at 60% workload, for periods calculated according to the 6-minute walk test results (land-based walking).
• Chair-based Exercise Program
The program content consists of breathing exercises and chair-supported exercises. Chest, abdominal and lateral basal breathing exercises will be performed 10 times each. Chair exercises are given in the exercise brochure. Exercises are performed with a chair support or sitting on a chair. In addition, patients will be asked to walk 30 minutes a day on flat ground at 60% workload, for periods calculated according to the 6-minute walk test results (land-based walking).

Locations

Country	Name	City	State
Turkey	Yedikule Chest Disease Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity assesment	The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.	Change from baseline at 2 months
Secondary	Dyspnea evaluation	Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.	Change from baseline at 2 months
Secondary	Respiratory muscle strength measurement	The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.	Change from baseline at 2 months
Secondary	Peripheral muscle strength measurement	Strength measurements of major peripheral muscle groups will be made with a digital myometer.	Change from baseline at 2 months
Secondary	Evaluation of quality of life	Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).	Change from baseline at 2 months
Secondary	Evaluation of fatigue	The fatigue severity scale: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity.; The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity Another way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7 Self-report scale	Change from baseline at 2 months
Secondary	Psychological status assessment	Hospital Anxiety Depression scale:The levels of anxiety and depression will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of =8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.	Change from baseline at 2 months
Secondary	Physical activity level assesment	The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. This measure assesses the types of intensity of physical activity and sitting time that people do as part of daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.	Change from baseline at 2 months
Secondary	Pulmonary function tests (PFTs)	PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines	Change from baseline at 2 months