Caregiver BurdenNCT07776470
Examining the Effectiveness of Ergonomics and Exercise Training in Caregivers
A study testing Ergonomic training, Exercise training and Standard information brochure in people with Caregiver Burden and Caregiver Burnout, run by Uskudar University.
Trial summary
Family and formal caregivers of partially or fully dependent individuals repeatedly perform physically demanding tasks such as lifting, transferring, repositioning, and hygiene care. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Caregiver Burnout, Musculoskeletal Pain
- What is being tested?
- Ergonomic training, Exercise training and Standard information brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Severe neurological, cardiovascular, or orthopaedic disease precluding exercise
- Pregnancy
- Spinal or extremity surgery within the previous 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Examining the Effectiveness of Ergonomics and Exercise Training in Caregivers: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Caregiver Burden, Caregiver Burnout, Musculoskeletal Pain
- Being tested
- Ergonomic training, Exercise training, Standard information brochure
- Keywords
- ergonomic, caregivers
- Medical subject headings
- Caregiver Burden, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic trainingOther
- 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 trainingOther
- 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 brochureOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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) Receives: Other: Standard information brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
. 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
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doç.Dr.Ömer Şevgin, Uskudar University
- Investigators
- Muhammet Yusuf Araz, Study chair, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776470
- Sponsor's protocol ID
- Uskudar29
- Other IDs
- Üsküdar University
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly; de-identified data may be made available on reasonable request to the corresponding investigator.
Publications
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.
PubMed 31905111Kim 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.
PubMed 37217300Mahmood 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.
PubMed 38427509
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Ergonomics and Exercise Training in Caregivers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07776470
- Acronym / sponsor ID
- Uskudar29
- Conditions
- Caregiver Burden, Caregiver Burnout, Musculoskeletal Pain
- Keywords
- ergonomic, caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ergonomic Training Only | Experimental | Other: Ergonomic trainingStructured 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 |
| Exercise Training Only | Experimental | Other: Exercise trainingStructured 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 |
| Combined Ergonomic and Exercise Training | Experimental | Other: Ergonomic training, Other: Exercise trainingThe 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 |
| Control (Wait-List, Brochure) | Active comparator | Other: Standard information brochureAfter 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) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Severe neurological, cardiovascular, or orthopaedic disease precluding exercise
- Pregnancy
- Spinal or extremity surgery within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomic training• 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. | Other | Combined Ergonomic and Exercise Training, Ergonomic Training Only |
| Exercise training• 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. | Other | Combined Ergonomic and Exercise Training, Exercise Training Only |
| Standard information brochure• 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. | Other | Control (Wait-List, Brochure) |
Primary outcome
. Change in caregiver burden - Zarit Burden Interview (ZBI)
Time frame: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)
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
5 secondary outcomes
Change in caregiver ergonomics and care knowledge - Caregiver Ergonomics and Care Knowledge Test
Time frame: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)
. Change in burnout - Maslach Burnout Inventory (MBI)
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)
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)
Time frame: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)
Change in fatigue - Piper Fatigue Scale (PFS)
Time frame: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 31905111Schulz 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.
- Background: PubMed 37217300Kim 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.
- Background: PubMed 38427509Mahmood 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly; de-identified data may be made available on reasonable request to the corresponding investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammet Yusuf Araz study chair
Üsküdar University
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic training, Exercise training and Standard information brochure in people with Caregiver Burden and Caregiver Burnout, run by Uskudar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ömer şevgin (+905069787535, omer.sevgin@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. Change in caregiver burden - Zarit Burden Interview (ZBI) (time frame: Baseline (week 0) and at the end of the twelve-week exercise program (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07776470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.