Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis

In this project, researchers evaluated the effects and differences of smart-video based game therapy and Otago-based structured exercises in women with osteoporosis; aimed to evaluate their applicability in women with osteoporosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Device: Smart-Video Based Game Therapy; Other: Otago Based Structured Exercise; Other: No intervention

Detailed Description

Osteoporosis is a musculoskeletal disease characterized by decreased bone mass and deterioration of the microstructure of the bone. The aim of the study is to use smart-based video-based play therapy and Otago-based structured exercises in women with osteoporosis; To evaluate the effect on bone quality, lower extremity muscle strength, balance, fear of falling, kinesiophobia and quality of life.

Working Groups Group 1: Smart Based Video Based Game Therapy Group Group 2: Otago Based Structured Exercise Group Group 3: Control Group Participants who agree to participate in the study are first evaluated with the Mental State Assessment - Standardized Mini Mental Test and Game Therapy group with the Simulator Illness Questionnaire and System Usability Scale, and if they meet the participation criteria, our study involves face-to-face interviews and blood and urine samples are routinely performed by the doctor on all patients at their first visit. Bone quality will be evaluated using bone turnover markers. Static balance with Romberg Test, dynamic balance with Four Square Step Test, functionality with Timed Up and Go Test, fear of falling with International Fall Activity Scale, kinesiophobia with Tampa Kinesiophobia Scale, muscle strength with Myometer, quality life with European Osteoporosis Association Quality of Life Questionnaire-41 will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yağmur KARAMAN POLAT, Research assistant; Phone Number: +905458718527; Email: ykaraman@medipol.edu.tr
• Study Contact Backup: Name: Gülay Aras Bayram; Phone Number: +905054966284; Email: garas@medipol.edu.tr

Study Locations

• Turkey
  • Ümraniye
    • Istanbul, Ümraniye, Turkey, 34764
      • Ümraniye Eğitim Araştırma Hastanesi
      • Contact: Yağmur KARAMAN POLAT, Research assistant; Phone Number: +905458718527; Email: ykaraman@medipol.edu.tr
      • Contact: Gülay ARAS BAYRAM, Associate professor; Phone Number: +905054966284; Email: garas@medipol.edu.tr
      • Principal Investigator: Yağmur KARAMAN POLAT, Research assistant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women in the climacteric period with osteoporosis between the ages of 45-65
• Those with DEXA T score < -2.5 SD,
• Those who have independent ambulation,
• Those who have no history of falling in the last year
• Those with a mini mental test score of 24 and above

Exclusion Criteria:

• Those who have participated in any exercise program in the last 3 months,
• Those who need support in ambulation,
• Those with a history of pathological fracture due to significant post-traumatic or malignancy,
• Those who have any systemic disease that may hinder the practices,
• Those with vestibular dysfunction,
• For participants in the smart video-based game therapy group, those who are not suitable to use the system according to the System Usability Scale and Simulator Illness Questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Smart-Video Based Game Therapy Group; The Active Arcade program will be practiced 2 days a week for 8 weeks. Individuals in this group will be given a 1-minute rest break between games. Sessions will be approximately 30 minutes. The selected games focus on balance, coordination and weight transfer.	Device: Smart-Video Based Game Therapy; The Active Arcade program will be practiced 2 days a week for 8 weeks. Individuals in this group will be given a 1-minute rest break between games. Sessions will be approximately 30 minutes. Selected games focus on balance, coordination and weight transfer.
Active Comparator: Otago Based Structured Exercise Group; Exercises will be done 2 days a week for 8 weeks and last approximately 30 minutes. In general, if individuals can perform 2 sets of 10 repetitions of movements at a difficulty level with quality, they can move on to a higher difficulty level. It consists of warm-up, balance and strengthening exercises. It was developed to increase balance.	Other: Otago Based Structured Exercise; Exercises will be done 2 days a week for 8 weeks and last approximately 30 minutes. In general, if individuals can perform 2 sets of 10 repetitions at a difficulty level with quality, they can move on to a higher difficulty level. It consists of warm-up, balance and strengthening exercises. It was developed to increase balance.
Active Comparator: Control group; A training presentation based on the guidelines and individuals' needs will be developed for participants in the control group. The presentation will include an infographic developed with the CANVA program, a test created with Google Forms, and a summary video developed with the Powtoon program. The created presentation will be presented online to individuals in the control group, and the participants will be followed by phone once a week for 8 weeks. The topics of the training will be: What is Osteoporosis, Osteoporosis Prevalence, Findings and Risk Factors, Diagnosis of Osteoporosis, Osteoporosis Prevention and Nutrition, Osteoporosis and Exercise, Preventing Falls.	Other: No intervention; A training presentation based on the guidelines and individuals' needs will be developed for participants in the control group. The presentation will include an infographic developed with the CANVA program, a test created with Google Forms, and a summary video developed with the Powtoon program. The created presentation will be presented online to individuals in the control group, and the participants will be followed by phone once a week for 8 weeks. The topics of the training will be: What is Osteoporosis, Osteoporosis Prevalence, Findings and Risk Factors, Diagnosis of Osteoporosis, Osteoporosis Prevention and Nutrition, Osteoporosis and Exercise, Preventing Falls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood and urine samples	Evaluation will be made with Bone turnover markers in the individuals' blood and urine samples. Bone turnover markers are classified as bone formation and resorption markers. Bone formation markers; serum osteocalcin (OC), serum total alkaline phosphatase (ALP); Bone resorption markers; urine deoxypyridinoline (DPD), free collagen cross-linked N-telopeptide (NTX).	eight weeks
Romberg test	It will be evaluated with the Romberg test. It is desirable to maintain postural control for 20-30 seconds with feet together, eyes open and closed. Additionally, the Romberg test is performed on a soft ground.	eight weeks
Four Square Step Test	It will be evaluated with the Four Square Step Test. By placing two canes on a flat surface, 4 squares are created and the squares are numbered. The participant is told that he/she must step into each square in the successive order (1-2-3-4-1-4-3-2-1) as fast as possible, without touching the canes, and that both feet must contact the ground in each square. The time to complete the sequence is recorded as a score. 2 scores are measured and the best one is taken.	eight weeks
time up and go test	Evaluation will be made with a time up and go test. A point is marked 3 m away from the chair where the participant is sitting. The participant is asked to get up from the chair, walk 3 m, turn back and sit on the chair again, and the time to complete the test is measured and recorded in seconds.	eight weeks
International Falls Effectiveness Scale	It will be evaluated with the International Falls Effectiveness Scale. It is a scale that evaluates how confident elderly individuals are in their daily life activities and shows their level of fear of falling. Each item of the scale, which consists of 16 items, is rated between 1 and 4 points (I am not worried at all: 1 point, I am a little worried: 2 points, I am quite worried: 3 points, I am very worried: 4 points). The total scale score ranges from 16 to 64, with a higher score indicating increased fear of falling.	eight weeks
Tampa Kinesiophobia Scale	The Tampa Kinesiophobia Scale developed by Miller, Kori and Todd will be used to evaluate kinesiophobia. It consists of 17 items including parameters of injury, re-injury, fear and avoidance in work-related activities. The scale uses a 4-point system, where 1 point means strongly disagree and 4 points means completely agree. A high score from the scale indicates a high kinesiophobia valu	eight weeks
myometer	The lower extremity muscle strength of all participants will be measured with a myometer. Muscle groups to be evaluated: Gluteus medius, gluteus maximus, adductor, quadriceps femoris, hamstring, gastrocnemius-soleus, tibialis anterior. Each measurement is repeated 3 times and the average of the test is recorded in kilograms.	eight weeks
European Osteoporosis Association Quality of Life Questionnaire-41	European Osteoporosis Association Quality of Life Questionnaire-41, such as pain (5 items), physical function (17 items), social activity (7 items), general health assessment (3 items) and mental function (9 items); It consists of 5 subscales examining five dimensions of health. It is scored on a 1-5 Likert type scale. A high score indicates poor quality of life.	eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Mini Mental Test	Standardized Mini Mental Test (MMSE) will be used to evaluate mental status. MMSE can be used to screen for cognitive impairment, estimate the severity of cognitive impairment at a particular point in time, track the course of cognitive changes in the individual over time, and evaluate the individual's response. It evaluates different cognitive status subheadings such as attention, language, memory, orientation, and visual spatial competence. MMSE is scored between 0-30 and >24 is interpreted as normal cognitive status.	eight weeks
Simulator Sickness Survey	Simulator Sickness Survey; 16 symptoms, such as eye fatigue, nausea, sweating and headache, are evaluated in 4 different severity levels (none, mild, moderate and severe). Symptoms; They are grouped into three categories: nausea, oculomotor disturbance and disorientation. Higher scores in each category indicate stronger disease symptoms.	eight weeks
System Usability Scale	It consists of 10 statements that help evaluate the ease of use of websites, software, hardware, mobile devices and other technological applications. The scale, which uses a 5-point Likert scale, is basically a survey created to evaluate usability. The average value is taken as 68, and a score greater than 68 indicates that the system is above average. Products with the highest usability evaluation are in the A+ class and the percentage range is between 96-100.	eight weeks

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: game therapy; rehabilitative game; otago exercise
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: MedipolU-FTR-YKP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No