Home Exercise Clinical Trial
Official title:
Investigation of Feasibility and Effectiveness of Home-Based Exercise Programs in Physiotherapy According to Disease Status: A Randomized Controlled Multicenter Study Protocol
Verified date | June 2024 |
Source | Necmettin Erbakan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Aim: In this study, the types of home-based exercise programs prepared for patients receiving physiotherapy services in different rehabilitation institutions; It is aimed to examine the applicability and effectiveness advantages according to disease status, age, gender, socioeconomic level, education level, confidence in the home program, and functional independence level. Study type: observational study Research question; To what extent do patients participate in home-based exercise programs?
Status | Completed |
Enrollment | 237 |
Est. completion date | January 17, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 78 Years |
Eligibility | Inclusion Criteria: - Having a clinical problem that causes physiotherapy and rehabilitation treatment - Being able to understand Turkish Exclusion Criteria: - Not wanting to participate in the study - Having a chronic disease or disability that would prevent the application of the home program. |
Country | Name | City | State |
---|---|---|---|
Turkey | Necmettin Erbakan University | Konya | Meram |
Lead Sponsor | Collaborator |
---|---|
Necmettin Erbakan University |
Turkey,
Kim JY, Lee MK, Lee DH, Kang DW, Min JH, Lee JW, Chu SH, Cho MS, Kim NK, Jeon JY. Effects of a 12-week home-based exercise program on quality of life, psychological health, and the level of physical activity in colorectal cancer survivors: a randomized controlled trial. Support Care Cancer. 2019 Aug;27(8):2933-2940. doi: 10.1007/s00520-018-4588-0. Epub 2018 Dec 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Functional independence measure, (FIM) | FIM analyzes two different aspects of disability, namely motor and cognitive functions. It consists of 6 functional parts: self-care, sphincter control, mobility, locomotion, communication and social perception. In the FIM, a total of 18 activities are evaluated for functional independence using a 7-point scale for each. The highest score that can be obtained is 126. The Turkish version of FIM was used in our study. | baseline, post-exercise (day 12) | |
Other | State Anxiety Scale | The state anxiety inventory was developed to measure a person's anxiety at a certain moment. The state anxiety inventory, consisting of 20 items, is a scale that determines how the individual feels at a certain moment and condition. The emotions or behaviors expressed in the state anxiety inventory items are answered by marking one of the options: (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree of intensity. There are 10 inverted expressions in the inventory. | baseline, post-exercise (day 12) | |
Other | Functional Independence Measure for Children (WeeFIM) | It contains a total of 18 items in 6 areas: self-care, sphincter control, transfers, movement, communication, social and cognitive. Each item in these areas is scored from 1 to 7, depending on whether the person receives help while performing the function, whether it is done on time, or whether an assistive device is required. When the given task is done completely with assistance, it is evaluated as 1, and when it is done completely independently, at the appropriate time and safely, it is evaluated as 7. | baseline, post-exercise (day 12) | |
Other | Gross Motor Function Classification System (GMFCS) | It is a 5-level classification system. Children with cerebral palsy under the age of 12 are divided into five levels based on gross motor functions such as self-initiated movements, sitting, and walking. Level 1: Walks independently. There are limitations in advanced gross motor skills. Level 2: walks without aids. There are limitations when walking in public. Level 3: Walks with an assistive device. There are limitations when walking in public. Level 4: It has a limitation. It is mobile by itself. Moves or uses a wheelchair (TS) in public. Level 5: mobilization is severely limited, although assistive technologies are used. | baseline, post-exercise (day 12) | |
Primary | Vizuel Analog Scala, (VAS) | VAS is an extremely simple, effective and repeatable measurement tool that requires minimal tools to measure both pain intensity and pain relief. It is a 10 cm long ruler drawn horizontally or vertically, starting with "No pain" and ending with "Unbearable pain". The patient is told to make a mark on this line that corresponds to the severity of his pain, intersecting this line. The distance from the lowest VAS level to the patient's mark is measured with a ruler to obtain a numerical index of the patient's pain intensity in cm or mm. | baseline, post-exercise (day 12) | |
Secondary | Fatigue Severity Scale, (FSS) | Fatigue Severity Scale is a scale with proven validity and reliability. FSS is shown as the best example among one-dimensional scales. The person indicates how much he or she agrees with each item by choosing a number from 1 to 7. 1 indicates that it does not agree at all, 7 indicates that it completely agrees. The score range of the scale, which consists of a total of 9 questions, is 9-63. A score of 36 or higher indicates severe fatigue. | baseline, post-exercise (day 12) |
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