Examining the Effectiveness of Ergonomics and Exercise Training in Caregivers

NCT07776470 | Not Yet Recruiting

• 2 other identifiers: Uskudar29Üsküdar University
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Family and formal caregivers of partially or fully dependent individuals repeatedly perform physically demanding tasks such as lifting, transferring, repositioning, and hygiene care. These tasks increase biomechanical loading and place caregivers at high risk of musculoskeletal complaints, which in turn increase perceived caregiver burden, burnout, and fatigue. Interventions for this population have most often been limited to information leaflets or theoretical instruction, and the active exercise component has usually been absent. Furthermore, teaching safe transfer techniques alone may be insufficient when caregivers lack the muscle strength, trunk (core) stability, and flexibility required to perform those techniques.

Conditions

Caregiver Burden; Caregiver Burnout; Musculoskeletal Pain

Keywords

ergonomic; caregivers

Outcome Measures

Primary Outcomes (1)

• . Change in caregiver burden - Zarit Burden Interview (ZBI)

  22-item Likert-type scale scored 0 ("never") to 4 ("nearly always"); total score 0-88, with higher scores indicating greater perceived burden. Turkish validity and reliability by İnci and Erdem (Cronbach α = 0.93). Time frame: Baseline (T0), week 12 (T1, end of intervention), and follow-up

  Baseline (week 0) and at the end of the twelve-week exercise program (week 12)

Secondary Outcomes (5)

• Change in caregiver ergonomics and care knowledge - Caregiver Ergonomics and Care Knowledge Test

  Baseline (week 0) and at the end of the twelve-week exercise program (week 12)

• . Change in burnout - Maslach Burnout Inventory (MBI)

  Baseline (week 0) and at the end of the twelve-week exercise program (week 12)

• Change in musculoskeletal symptoms - Nordic Musculoskeletal Questionnaire (NMQ)

  Baseline (week 0) and at the end of the twelve-week exercise program (week 12)

• Change in sleep quality - Pittsburgh Sleep Quality Index (PSQI)

  Baseline (week 0) and at the end of the twelve-week exercise program (week 12)

• Change in fatigue - Piper Fatigue Scale (PFS)

  Baseline (week 0) and at the end of the twelve-week exercise program (week 12)

Study Arms (4)

Ergonomic Training Only

EXPERIMENTAL

Structured theoretical and hands-on ergonomic training delivered once a month for 12 weeks (3 sessions), face-to-face and/or via synchronous/asynchronous video modules. Content: biomechanical body mechanics, in-bed positioning, sitting the care recipient up, bed-to-chair transfer techniques, use of assistive devices, and home environmental modification to protect low back and neck health. - Intervention type: Other - Intervention name: Ergonomic training

Other: Ergonomic training

Exercise Training Only

EXPERIMENTAL

Structured exercise programme delivered 3 sessions per week for 12 weeks as face-to-face practice or video-supported guidance with home exercise monitoring. Content: postural exercises, core stabilization, trunk and extremity strengthening, stretching, and breathing exercises. Each session lasts approximately 30-45 minutes. - Intervention type: Other - Intervention name: Exercise training

Other: Exercise training

Combined Ergonomic and Exercise Training

EXPERIMENTAL

The ergonomic training module (once a month) and the exercise protocol (3 sessions per week) delivered concurrently for 12 weeks, face-to-face and/or video-supported. - Intervention type: Other - Intervention name: Combined ergonomic and exercise training

Other: Ergonomic training; Other: Exercise training

Control (Wait-List, Brochure)

ACTIVE COMPARATOR

After baseline assessment, participants receive a standard printed information brochure covering general health recommendations, the importance of spinal health, and basic principles to observe during routine caregiving. No active exercise or face-to-face practical ergonomic training is provided. Participants are contacted once a month by telephone during the 12-week period to monitor changes in health status; no exercise or ergonomic guidance is given. After all assessments are completed, training materials and videos are offered to this group for ethical reasons. - Intervention type: Other - Intervention name: Standard information brochure (wait-list control)

Other: Standard information brochure

Interventions

Ergonomic training OTHER

• Description: Structured theoretical and hands-on ergonomic training delivered once a month over the 12-week intervention period (3 sessions in total), face-to-face and/or through synchronous or asynchronous video modules, by a physiotherapist. Content covers biomechanical body mechanics, in-bed positioning, sitting the care recipient up, bed-to-chair transfer techniques, use of assistive devices, and modification of the home environment to protect low back and neck health. Each session lasts approximately 30-45 minutes.

Combined Ergonomic and Exercise Training; Ergonomic Training Only

Exercise training OTHER

• Description: Structured exercise programme delivered 3 sessions per week for 12 weeks (36 sessions in total) as face-to-face supervised practice or video-supported guidance with home exercise monitoring, under the supervision of a physiotherapist. The programme includes postural exercises, core stabilization, trunk and extremity strengthening, stretching, and breathing exercises. Each session lasts approximately 30-45 minutes. Perceived exertion is monitored with the Borg scale and sessions are modified or terminated if adverse symptoms occur.

Combined Ergonomic and Exercise Training; Exercise Training Only

Standard information brochure OTHER

• Description: A standard printed brochure covering general health recommendations, the importance of spinal health, and basic principles to observe during routine caregiving, given once after the baseline assessment. Participants are contacted by telephone once a month during the 12-week period to record any change in health status or any new surgery or acute illness; no exercise or ergonomic guidance is provided during these calls. After all assessments are completed, training materials and videos are offered to this group for ethical reasons.

Control (Wait-List, Brochure)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-65 years
• Providing care to a dependent individual for at least 6 months, at least 4 hours per day
• Literate, with no intellectual or hearing impairment preventing communication
• Not having participated in a regular exercise or ergonomic training programme in the previous 6 months
• Willing to participate and provide written informed consent

You may not qualify if:

• Severe neurological, cardiovascular, or orthopaedic disease precluding exercise
• Pregnancy
• Spinal or extremity surgery within the previous 3 months

Sponsors & Collaborators

• Uskudar University: lead

Related Publications (3)

• Schulz R, Beach SR, Czaja SJ, Martire LM, Monin JK. Family Caregiving for Older Adults. Annu Rev Psychol. 2020 Jan 4;71:635-659. doi: 10.1146/annurev-psych-010419-050754.

  PMID: 31905111 BACKGROUND

• Kim JY, Tak SH, Lee J, Choi H. Effects of Physical Exercise Program for Older Family Caregivers of Persons With Dementia. Am J Alzheimers Dis Other Demen. 2023 Jan-Dec;38:15333175231178384. doi: 10.1177/15333175231178384.

  PMID: 37217300 BACKGROUND

• Mahmood Q, Habibullah S, Aurakzai HU. Effectiveness of simple and basic home-based exercise programs including pediatric massage executed by caregivers at their homes in the management of children with spastic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2024;17(1):97-106. doi: 10.3233/PRM-220135.

  PMID: 38427509 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden; Musculoskeletal Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Muhammet Yusuf Araz

  Üsküdar University

  STUDY CHAIR

Central Study Contacts

ömer şevgin

CONTACT

+905069787535; omer.sevgin@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share