NCT06577740

Brief Summary

The aim of our study was to investigate the effects of group-based and dual-task focused otago exercises on kinesiophobia, musculoskeletal system and psychosocial status in geriatric individuals with kinesiophobia. In the study : 1. Do group-based and dual-task focused otago exercises have an effect on kinesiophobia in geriatric individuals with kinesiophobia? 2. Do group-based and dual-task focused otago exercises have an effect on the musculoskeletal system in geriatric individuals with kinesiophobia? 3. Do group-based and dual-task focused otago exercises have an effect on the psychosocial status of geriatric individuals with kinesiophobia? 4. Do group-based and dual-task focused otago exercises have an effect on cognitive function in geriatric individuals with kinesiophobia? The questions were answered.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 27, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

geriatricskinesiophobiaOtago exercisesdual task

Outcome Measures

Primary Outcomes (7)

  • Tampa Kinesiophobia Scale

    It is a 17-question scale measuring fear of movement/re-injury.

    Duration of change in 4 week

  • Berg Balance Scale

    It is a scale that includes 14 different types of activities aimed at questioning dynamic and static balance.

    Duration of change in 4 week

  • Geriatric Depression Scale Short Form

    It is a scale consisting of 15 questions that determines the level of depression in geriatric individuals.

    Duration of change in 4 week

  • 5 times sit and stand test

    Used to assess fall risk and lower extremity muscle strength.

    Duration of change in 4 week

  • Mini Mental Status Test

    It is a scale used to assess cognitive function.

    Duration of change in 4 week

  • Montreal Cognitive Assessment Test

    It is a scale used to identify individuals with mild cognitive impairment and to distinguish them from healthy geriatric individuals.

    Duration of change in 4 week

  • Timed Up and Go Test

    It is a scale used to assess mobility in geriatric individuals.

    Duration of change in 4 week

Study Arms (2)

Otago Exercise Group

OTHER

Participants in the study were given group otago exercises for 4 weeks, face to face, once a week for 30 minutes. They were also given brochures containing otago exercises twice a week and followed up remotely. They were asked to walk normally for 30 minutes, 2 days a week. Then they entered a 4-week cleansing period.

Other: Otago Exercise

Dual Task Focused Otago Exercise Group

EXPERIMENTAL

After a 4-week washout period, participants in the study were given group-based otago exercises and dual-task exercises once a week for 4 weeks. They were given a brochure containing otago exercises including dual-task exercises twice a week and were applied individually and monitored remotely. They were asked to walk normally 2 days a week.

Other: Dual Task Focused Otago Exercise

Interventions

Group-based otago exercises were performed for 4 weeks. They were also given a brochure containing otago exercises twice a week and applied individually and followed remotely. They were asked to walk normally for 30 minutes twice a week. They then entered a 4-week washout period.

Otago Exercise Group

After a 4-week washout period, face-to-face group-based and dual-task focused otago exercises were applied once a week for 4 weeks. Participants were given a brochure containing otago exercises including dual-task exercises twice a week and applied individually and monitored remotely. They were asked to walk normally for 30 minutes twice a week.

Dual Task Focused Otago Exercise Group

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals aged 65 and over
  • Participants who can read and write in Turkish
  • Participants who scored 38 or higher on the Tampa Kinesiophobia Scale
  • Participants who received 24 points or more from the Mini Mental State Test
  • Participating in the study voluntarily
  • Individuals who do not have any disability such as vision, hearing, limb loss, etc.
  • Participants who can walk independently

You may not qualify if:

  • Medication status that increases the risk of falls (determined based on information from nursing home nurses and physiotherapists).
  • Individuals who are bedridden or wheelchair bound
  • Individuals with diagnosed mental or psychological problems (The individual's inability to perceive the scales to be applied)
  • Individuals with diagnosed serious neurological or orthopedic problems
  • Individuals with diagnosed serious pulmonary or cardiac disease
  • Individuals with uncontrolled hypertension or diabetes
  • Those with a history of syncope or vertigo attacks in the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amine Ataç

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.

    PMID: 36339194BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 29, 2024

Study Start

April 15, 2024

Primary Completion

July 3, 2024

Study Completion

August 8, 2024

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

It will be evaluated if the researchers are contacted via their e-mail addresses.

Locations