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

NCT06506409 | Not Yet Recruiting

• 1 other identifier: MedipolU-FTR-YKP-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

game therapy; rehabilitative game; otago exercise

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Standardized Mini Mental Test

  eight weeks

• Simulator Sickness Survey

  eight weeks

• System Usability Scale

  eight weeks

Study Arms (3)

Group 1: Smart-Video Based Game Therapy Group

ACTIVE COMPARATOR

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

Otago Based Structured Exercise Group

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Interventions

Smart-Video Based Game Therapy 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.

Group 1: Smart-Video Based Game Therapy Group

Otago Based Structured Exercise 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.

Otago Based Structured Exercise Group

No intervention 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.

Control group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Women in the climacteric period with osteoporosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Ümraniye Eğitim Araştırma Hastanesi

Istanbul, Ümraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yağmur KARAMAN POLAT, Research assistant

CONTACT

+905458718527; ykaraman@medipol.edu.tr

Gülay ARAS BAYRAM

CONTACT

+905054966284; garas@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: We have three parallel groups: Two treatment groups and one control group

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)