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.
Design and setting. The trial is designed according to the Declaration of Helsinki, Good Clinical Practice guidelines, and the CONSORT 2010 statement. All assessment, education, and exercise sessions will be conducted in the environment where participants provide care (the care recipient's home) and/or in the practice areas of the affiliated home-care/rehabilitation/support unit. Assessment and application areas will be standardized (standard chair, exercise mat, and a safe environment suitable for simulating patient transfer). The study will start only after ethics committee approval and written informed consent. Sampling and randomization. Caregivers meeting the eligibility criteria will be enrolled by consecutive sampling. Participants will be allocated 1:1:1:1 to four groups by block randomization (block size 4 or 8) using a computer-based random number generator. The randomization list will be prepared by an independent researcher who takes no part in assessment or intervention delivery, and allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Sample size. Sample size was calculated a priori with G\*Power 3.1.9.7 for a repeated-measures ANOVA (within-between interaction) testing the group × time interaction of the primary outcome (ZBI) in a 4 (group) × 3 (time) mixed design, with effect size f = 0.25, α = 0.05, power = 0.80, and correlation among repeated measures = 0.50. The required total sample was 40 (actual power 0.805). To allow balanced 1:1:1:1 block randomization, the minimum required sample was set at 48 participants (12 per group; power 88.7%), and with an approximately 20% allowance for expected drop-out, a total of 64 caregivers (16 per group) is planned (power 96.7%). Sensitivity analysis indicated that N = 48 detects f = 0.225 and N = 64 detects f = 0.193 at 80% power. Blinding. Because of the nature of the educational and exercise interventions, neither participants nor the treating physiotherapist can be blinded. A single-blind (outcome assessor blinded) design will therefore be used: all T0, T1, and T2 assessments will be performed by an independent physiotherapist/researcher unaware of group allocation, and the researcher performing the statistical analysis will also be blinded to group codes (A/B/C/D). Statistical analysis. Analyses will be performed with IBM SPSS Statistics 27.0 (and R 4.3, nlme/lme4, where required); two-sided α = 0.05. Primary analyses will follow the intention-to-treat principle on all randomized participants, with a confirmatory per-protocol analysis restricted to participants attending at least 75% of sessions. Normality (Shapiro-Wilk, skewness/kurtosis, Q-Q plots), homogeneity of variances (Levene), equality of covariance matrices (Box's M), and sphericity (Mauchly, with Greenhouse-Geisser or Huynh-Feldt correction) will be examined. The primary hypothesis will be tested through the group × time interaction of a 4 × 3 mixed-design (repeated measures) ANOVA. If clinically relevant baseline imbalance is present, ANCOVA adjusting for T0 scores will be used. Where normality is seriously violated, data transformation or non-parametric alternatives (Friedman; Kruskal-Wallis H with Dunn-Bonferroni post hoc) will be applied. Post hoc between-group comparisons will use Tukey HSD (or Games-Howell if variances are unequal) and within-group comparisons Bonferroni-adjusted pairwise tests; Benjamini-Hochberg false discovery rate correction will be applied to secondary outcomes. Dichotomous Nordic Musculoskeletal Questionnaire data will be analysed with Cochran Q and McNemar tests within groups and chi-square or Fisher's exact test between groups, with relative risks and odds ratios and 95% confidence intervals. Effect sizes will be reported as partial eta squared and Cohen's d with 95% confidence intervals; for ZBI, responder rates based on the minimal clinically important difference and the number needed to treat will also be presented. Safety. All exercise and transfer practice will be supervised by a physiotherapist on safe flooring and according to biomechanical principles. Perceived exertion will be monitored (Borg scale). In case of any adverse event (increased musculoskeletal pain, excessive fatigue, dizziness), the session will be modified or terminated and the event recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
48
• 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.
• 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.
• 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.
. 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)
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)
. 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)
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)
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)
Change in fatigue - Piper Fatigue Scale (PFS)
22 items scored 0-10 across behavioural/severity, affective, sensory, and cognitive/mood subscales; higher scores indicate greater fatigue. Turkish version by Can (Cronbach α = 0.94).
Time frame: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)
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