Examining the Effectiveness of Ergonomics and Exercise Training in Caregivers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorUskudar University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Severe neurological, cardiovascular, or orthopaedic disease precluding exercise
Pregnancy
Spinal or extremity surgery within the previous 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Ergonomic training
Other intervention• 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.
Exercise training
Other intervention• 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.
Standard information brochure
Other intervention• 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.
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: Ergonomic Training OnlyExperimental treatment 1 intervention
Group B: Exercise Training OnlyExperimental treatment 1 intervention
Group C: Combined Ergonomic and Exercise TrainingExperimental treatment 2 interventions
Group D: Control (Wait-List, Brochure)Active comparator 1 intervention
Trial outcomes
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
Time frame
Baseline (week 0) and at the end of the twelve-week exercise program (week 12)Secondary outcomes
1
Change in caregiver ergonomics and care knowledge - Caregiver Ergonomics and Care Knowledge Test
Investigator-developed multiple-choice and true/false test covering biomechanical body mechanics, safe patient transfer, postural protection, and home environmental modification; correct answers score 1, incorrect or blank 0.
Time frame
Baseline (week 0) and at the end of the twelve-week exercise program (week 12)2
. Change in burnout - Maslach Burnout Inventory (MBI)
22 items, three subscales (emotional exhaustion 9 items, depersonalization 5 items, personal accomplishment 8 items), scored 0-4. Higher emotional exhaustion and depersonalization and lower personal accomplishment scores indicate greater burnout. Turkish version by Çam (Cronbach α 0.67-0.83).
Time frame
Baseline (week 0) and at the end of the twelve-week exercise program (week 12)3
Change in musculoskeletal symptoms - Nordic Musculoskeletal Questionnaire (NMQ)
Dichotomous (yes/no) items on musculoskeletal symptoms during the past 12 months and past 7 days and activity limitation in 9 anatomical regions (neck, shoulder, upper back, low back, elbow, hand/wrist, hip/thigh, knee, ankle/foot). Turkish cultural adaptation by Kahraman et al.
Time frame
Baseline (week 0) and at the end of the twelve-week exercise program (week 12)4
Change in sleep quality - Pittsburgh Sleep Quality Index (PSQI)
19 items, 7 components each scored 0-3; total score 0-21, with scores above 5 indicating poor sleep quality. Turkish version by Ağargün et al. (Cronbach α = 0.80).
Time frame
Baseline (week 0) and at the end of the twelve-week exercise program (week 12)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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