NCT05909449

Brief Summary

The aim of this research is to create and implement an exercise program so that primary caregivers can have the correct posture and improve health-related physical fitness parameters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 3, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

June 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

May 10, 2023

Last Update Submit

June 11, 2023

Conditions

Keywords

posturePhysical Fitnesscare provider

Outcome Measures

Primary Outcomes (10)

  • The Nordic Musculoskeletal Questionnaire

    NMQ is a questionnaire that evaluates low back, neck, shoulder and general musculoskeletal complaints with standardized questions. In NMQ; Pain and discomfort in nine mapped and marked areas of the body (feet-ankles, knees, thighs-hips, wrists-hands, waist, elbows, back, shoulders, neck), and whether this is interfering with normal work being questioned

    twice (before and after 6 week exercise program)

  • Oswestry Low Back Pain Disability Index

    It consists of 10 titles (Pain sensitivity, self-care, weight lifting, reading, headaches, concentration, study/work, driving, sleep, and social activities). Each question has 6 answer options that measure the severity of pain or limitation. Scoring is done between 0-5. The total score is between 0-50. There is no limitation between 0-4 points according to the total score; 5-14 mild limitation; 15-24 moderately restricted; 25-34 severe limitation; 34 and above are classified as completely restricted

    twice (before and after 6 week exercise program)

  • The shortened disabilities of the arm, shoulder and hand questionnaire (Quick DASH)

    Q-DASH is a regional outcome measure developed for upper extremity musculoskeletal disorders and includes 11 questions. Each question is scored on a 5-point scale and a final score ranging from 0 (no disability) to 100 (severe disability) is calculated.

    twice (before and after 6 week exercise program)

  • The Oswestry Disability Index (ODI)

    It consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling and the degree of pain. Each item is graded between 0-5. The maximum score is 50 points; It is evaluated as severe disability between 31-50 points, moderate between 11-30 points and mild disability between 1-10 points.

    twice (before and after 6 week exercise program)

  • Two Minute Walk Test (2MWT)

    2DYT is carried out in a 30 meter long corridor. The starting and ending points are determined by marking the corridor every 3 meters. A colored cone is placed in the turning zones. Participants are asked to walk the 30-meter corridor for 2 minutes at their own walking speed without running. Distance traveled in 2 minutes is recorded

    twice (before and after 6 week exercise program)

  • Sit and Reach Test

    The test will be used to assess lower extremity flexibility. For this test, the participants will be asked to rest their feet on the test bench while in a long sitting position with their knees straight, and without bending their knees, put their hands on each other and extend their arms towards the test bench in front. 3 repetitions will be made and the average value will be recorded.

    twice (before and after 6 week exercise program)

  • force platform

    Balance and sole pressure distribution will be evaluated with the force platform. Balance parameters and footpad pressure distribution evaluations of the cases will be recorded with a force platform (Matscan, TekScan, Boston, MA, USA) with a recording speed of 100Hz and a resolution of 4 senses/cm². Measurements; It will be performed with eyes open and closed, in free standing position and on one foot (first on the dominant, then on the non-dominant foot). For the measurement at each position, force platform records will be taken for 30 seconds. Analysis of the data will be done using Matscan 7.10 (TekScan, Boston, MA) software provided by the manufacturer. To evaluate the balance, center of gravity range of motion (cm2), antero-postero oscillation (cm) and medio-lateral oscillation (cm) values will be recorded.

    twice (before and after 6 week exercise program)

  • Back reach test

    This test evaluates shoulder flexibility. While in a standing position, one arm is externally rotated with the fingers extended and the palm facing the back, reaching the lowest point of the back over the shoulder towards the back and while doing this, the other arm is internally rotated, with the palm facing forward and the fingers again. While in extension, he will be asked to reach the highest point on his back. The distance between the middle fingers placed on the back will be recorded

    twice (before and after 6 week exercise program)

  • The Zarit Care Burden Scale (ZBVYS)

    It was developed by Zarit et al to evaluate the effects of the caregiving process on the caregiver. It consists of 22 statements that determine the effect of caregiving on the life of the individual. Although a maximum of 88 points can be obtained from a 5-point Likert-type scale (1=never, 5=always), higher scores indicate higher caregiving burden

    twice (before and after 6 week exercise program)

  • Warwick-Edinburgh Mental Well-being

    It was developed by Tennant et al. to measure the mental well-being of the caregiver. The scale consists of 14 items covering psychological well-being and subjective well-being. It is a 5-point Likert-type scale, with the lowest 14 points and the highest 70 points. High scores from the scale indicate high mental (psychological) well-being.

    twice (before and after 6 week exercise program)

Study Arms (1)

research group

EXPERIMENTAL

provide primary care services to individuals with physical disabilities

Other: exercises

Interventions

participants will be given a structured home exercise program

research group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals between the ages of 18-65
  • To give primary care to a person with a physical disability
  • Being caring for at least 6 months
  • Voluntarily performing care
  • Being able to understand and read Turkish as a language
  • To have sufficient cognitive level to answer the scale questions with the basic interview
  • Volunteer to participate in and maintain an exercise program
  • Regularly participating in the evaluation and exercise program defined during the project process

You may not qualify if:

  • Caring for a paid job other than voluntarily
  • Encountering a disease related to the caregiver during the working process
  • Having any known musculoskeletal disease
  • Having a known spinal problem such as scoliosis, kyphosis, kyphoscoliosis
  • Having undergone surgery affecting the musculoskeletal system in the last 1 month
  • History of uncontrollable arrhythmia and/or hypertension
  • Having any neurological, cardiovascular, respiratory, orthopedic and metabolic disease that will prevent participation in the exercise program
  • Being pregnant for female individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • NİLÜFER KABLAN

    associate professor

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 18, 2023

Study Start

May 3, 2023

Primary Completion

June 21, 2023

Study Completion

July 3, 2023

Last Updated

June 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations