Home ExerciseNCT06142331
Applicability of Home-based Exercise Programs in Physiotherapy
An observational study of Home Exercise, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 78 years
- Conditions the study is for
- Home Exercise
- How many people
- 237 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2023to 17 Jan 2024
- How long will I take part?
- 12 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 78 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population/Sample of the Study: The population of the study consists of patients receiving Physiotherapy and Rehabilitation services in the hospital and rehabilitation center where the health services where the research will be carried out are provided. The sample of the research: Consists of 60 volunteer participants under the age of 18 and 177 participants over the age of 18 in the relevant units of three different health institutions, as stated, consisting of women and men. Only 89 female and male volunteer participants over the age of 18 will be included in the study in the physical therapy and rehabilitation unit of our hospital.
Who may be able to join
- Having a clinical problem that causes physiotherapy and rehabilitation treatment
- Being able to understand Turkish
Who cannot join
- Not wanting to participate in the study
- Having a chronic disease or disability that would prevent the application of the home program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Feasibility and Effectiveness of Home-Based Exercise Programs in Physiotherapy According to Disease Status: A Randomized Controlled Multicenter Study Protocol
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?
Read the detailed description
Background and rationale; It is common to use home exercise programs in organizations that provide physiotherapy services. The home exercise program is specially created by physiotherapists according to the patient's needs and individual characteristics. The prepared program is explained to the patient how to do the exercise at home by various means such as verbal explanation, practical demonstration, giving brochures or video recording. Home program exercises contribute positively to the rehabilitation process by enabling the patient to take an active role in the rehabilitation process and giving the patient personal responsibility. Supporting the treatments given in health institutions with home program exercises increases the effectiveness of the treatment. In addition, preparing a home exercise program is a frequently used method in cases where access to healthcare is difficult due to various reasons.
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.
Research processes; Participants will first be interviewed face to face and preliminary evaluation data will be obtained before a home exercise program is given.
The patient's gender, age, diagnosis, education level, socioeconomic level, functional dependency level, state anxiety level, fatigue severity scale, and pain level score will be recorded. The type of exercise given and the type of learn home-based exercise will be recorded.
12 days after the routine home exercise program, the final data will be collected by the researchers from the patients face to face or by phone for patients who cannot attend the appointment.
- Conditions
- Home Exercise
- Keywords
- home exercise, exercise behavior, exercise compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, post-exercise (day 12)
Secondary outcomes (1)
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.
Measured: baseline, post-exercise (day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start17 Nov 2023
- Primary completion1 Dec 2023
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Home ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 237 participants (actual)
- Target duration
- 12 Days
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Altuntas Yilmaz, Necmettin Erbakan University
- Investigators
- Neslihan Altuntaş Yılmaz, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142331
- Sponsor's protocol ID
- ADagbasi002
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30564936
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Feasibility and Effectiveness of Home-Based Exercise Programs in Physiotherapy According to Disease Status: A Randomized Controlled Multicenter Study Protocol
- ClinicalTrials.gov ID
- NCT06142331
- Acronym / sponsor ID
- ADagbasi002
- Conditions
- Home Exercise
- Keywords
- home exercise, exercise behavior, exercise compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Background and rationale; It is common to use home exercise programs in organizations that provide physiotherapy services. The home exercise program is specially created by physiotherapists according to the patient's needs and individual characteristics. The prepared program is explained to the patient how to do the exercise at home by various means such as verbal explanation, practical demonstration, giving brochures or video recording. Home program exercises contribute positively to the rehabilitation process by enabling the patient to take an active role in the rehabilitation process and giving the patient personal responsibility. Supporting the treatments given in health institutions with home program exercises increases the effectiveness of the treatment. In addition, preparing a home exercise program is a frequently used method in cases where access to healthcare is difficult due to various reasons.
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.
Research processes; Participants will first be interviewed face to face and preliminary evaluation data will be obtained before a home exercise program is given.
The patient's gender, age, diagnosis, education level, socioeconomic level, functional dependency level, state anxiety level, fatigue severity scale, and pain level score will be recorded. The type of exercise given and the type of learn home-based exercise will be recorded.
12 days after the routine home exercise program, the final data will be collected by the researchers from the patients face to face or by phone for patients who cannot attend the appointment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Days
Who may qualify
- Ages
- Up to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population/Sample of the Study: The population of the study consists of patients receiving Physiotherapy and Rehabilitation services in the hospital and rehabilitation center where the health services where the research will be carried out are provided. The sample of the research: Consists of 60 volunteer participants under the age of 18 and 177 participants over the age of 18 in the relevant units of three different health institutions, as stated, consisting of women and men. Only 89 female and male volunteer participants over the age of 18 will be included in the study in the physical therapy and rehabilitation unit of our hospital.
Key inclusion criteria (2 listed)
- Having a clinical problem that causes physiotherapy and rehabilitation treatment
- Being able to understand Turkish
Key exclusion criteria (2 listed)
- Not wanting to participate in the study
- Having a chronic disease or disability that would prevent the application of the home program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vizuel Analog Scala, (VAS)
Time frame: baseline, post-exercise (day 12)
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.
1 secondary outcome
Fatigue Severity Scale, (FSS)
Time frame: baseline, post-exercise (day 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 30564936Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neslihan Altuntaş Yılmaz principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Exercise, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vizuel Analog Scala, (VAS) (time frame: baseline, post-exercise (day 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06142331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.