Applicability of Home-based Exercise Programs in Physiotherapy

June 3, 2024 updated by: Neslihan Altuntas Yilmaz, Necmettin Erbakan University

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?

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Meram
      • Konya, Meram, Turkey
        • Necmettin Erbakan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, post-exercise (day 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale, (FSS)
Time Frame: baseline, post-exercise (day 12)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional independence measure, (FIM)
Time Frame: baseline, post-exercise (day 12)
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)
State Anxiety Scale
Time Frame: baseline, post-exercise (day 12)
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)
Functional Independence Measure for Children (WeeFIM)
Time Frame: baseline, post-exercise (day 12)
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)
Gross Motor Function Classification System (GMFCS)
Time Frame: baseline, post-exercise (day 12)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Principal Investigator: Neslihan Altuntaş Yılmaz, Necmettin Erbakan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ADagbasi002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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