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

NCT ID: NCT06506409

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We have three parallel groups: Two treatment groups and one control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Smart-Video Based Game Therapy

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Otago Based Structured Exercise

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Yağmur KARAMAN POLAT

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ümraniye Eğitim Araştırma Hastanesi

Istanbul, Ümraniye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Yağmur KARAMAN POLAT, Research assistant

Role: CONTACT

+905458718527

Gülay ARAS BAYRAM

Role: CONTACT

+905054966284

Facility Contacts

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Yağmur KARAMAN POLAT, Research assistant

Role: primary

+905458718527

Gülay ARAS BAYRAM, Associate professor

Role: backup

+905054966284

Other Identifiers

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MedipolU-FTR-YKP-01

Identifier Type: -

Identifier Source: org_study_id

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