Mental Health CareNCT07236424
Effectiveness of Exercise, Walking, and Education on Mental Health, Mobility and Quality of Life in Elderly Residents of Nursing Homes
A study testing Physiotherapy in people with Mental Health Care and Depression Anxiety Disorder, run by University of Mostar at 1 site in Bosnia and Herzegovina.
Trial summary
Clinical Trial This clinical trial aims to determine the impact of physiotherapy interventions on mental health, quality of life, and spinal mobility in older adults. The physiotherapy intervention will consist of group exercise therapy (3 times a week, 40 minutes, 4 weeks in total), walking activities (3 times a… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mental Health Care, Depression Anxiety Disorder, Quality of Life
- What is being tested?
- Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 20 Nov 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- both sexes, aged ≥ 65 years, with an optimal level of functional and cognitive abilities necessary to perform the exercises and understand the measurement scales.
Who cannot join
- significant cognitive and neurological impairments, functionally immobile persons, and persons who refuse to participate.
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Nursing home "Ministro", Žepče
Žepče, 72230
About this study
Official title: Effectiveness of Short-term Supervised Group Exercise Therapy, Walking and Education on Mental Health, Quality of Life and Mobility in Elderly Residents of Nursing Homes
Clinical Trial This clinical trial aims to determine the impact of physiotherapy interventions on mental health, quality of life, and spinal mobility in older adults. The physiotherapy intervention will consist of group exercise therapy (3 times a week, 40 minutes, 4 weeks in total), walking activities (3 times a week, 30 minutes, 4 weeks in total), and education on optimal positions and movements in daily activities (one session lasting 60 minutes)
The main questions it aims to answer are:
- Are group exercise therapy and walking optimal for reducing symptoms of depression and anxiety and improving quality of life in older adults placed in nursing homes in a short period of time
- Do physiotherapy interventions improve spinal mobility (anteflexion and extension)?
Read the detailed description
Population ageing is a worldwide phenomenon resulting from increased living standards, improved healthcare, and decreased birth rates. The proportion of people aged 60 and over continues to grow and is expected to exceed two billion by 2050, with 80% of them living in developed countries.
Ageing is associated with a decline in physical and mental capacities, increased risk of chronic diseases, and social isolation, leading to higher healthcare and social costs. However, many of these challenges can be prevented or mitigated through timely interventions. Global health initiatives promote Healthy and Active Ageing, focusing on maintaining longevity, well-being, and quality of life. Physical activity and exercise therapy are the most effective interventions for promoting physical and mental health, highlighting the essential role of physiotherapy. Physiotherapists are well-positioned to promote healthy ageing due to their accessibility, cost-effectiveness, and expertise in managing a wide range of health conditions. Increasing evidence shows that physiotherapy not only enhances physical function but also contributes significantly to the mental well-being of older adults.
Recent systematic reviews with meta-analyses have reported positive effects of exercise therapy and physical activity on reducing depression, anxiety, and improving quality of life among older adults. An umbrella review reports high benefits of physical activity for improving symptoms of depression, anxiety, and distress across a wide range of adult populations, including the general population, people with diagnosed mental health disorders, and people with chronic disease. A systematic review with meta-analysis confirmed exercise as an effective treatment for anxiety. However, the heterogeneity of the included studies does not provide clearer information about the optimal exercise methods, as well as the necessary parameters and ways of implementing exercise therapy. In addition, individual studies show conflicting results on the effects of physical activity in nursing home residents; one reports benefits of a structured exercise program on depressive symptoms and quality of life, while another finds no significant improvement with supervised moderate aerobic and resistance training.
Thus, this study aim is to determine the optimal methods of exercise therapy and physical activity, as well as other parameters such as frequency, intensity, supervision, and method of implementation, in improving mental health and quality of life in elderly people in a nursing home.
- Being tested
- Physiotherapy
- Keywords
- Mental Health, Depression, Anxiety, Quality of Life, Older Adults, Exercise Therapy, Physiotherapy, Walking
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
- Exercise therapy - stretching and breathing exercises, stabilization exercises, mobility exercises, and balance and coordination exercises. The exercises will be performed in a standing and lying position, with the possibility of using aids - gymnastic ball and resistance bands. Implementation - three times a week for 40 minutes, for a total of four weeks.
- Walking activity - three times a week for half an hour.
- Education on optimal positions and movement in everyday life activities - at the beginning of the study in one session lasting 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 22 participants Receives: Behavioral: Physiotherapy |
| Control group | No intervention | 20 participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and Anxiety
Hospital Anxiety and Depression Scale (0=best, 21=worst)
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
Self-reported measure of health
The 36-Item Short Form Survey; Eight domains: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain and General Health (0 - worst, 100 - best)
Measured: From enrollment to end of the treatment at 4 weeks
Range of motion of extension and flexion in the lumbar spine
Goniometer (extension 0-40°, flexion 0-70°; higher score best)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025
- Primary completion5 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mental Health CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonija Hrkać, University of Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236424
- Sponsor's protocol ID
- Studija V
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lok N, Lok S, Canbaz M. The effect of physical activity on depressive symptoms and quality of life among elderly nursing home residents: Randomized controlled trial. Arch Gerontol Geriatr. 2017 May-Jun;70:92-98. doi: 10.1016/j.archger.2017.01.008. Epub 2017 Jan 16.
PubMed 28110207Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther AM, Spencer A, Thorogood M, Atherton N, Bremner SA, Devine A, Diaz-Ordaz K, Ellard DR, Potter R, Spanjers K, Taylor SJ. Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial. Lancet. 2013 Jul 6;382(9886):41-9. doi: 10.1016/S0140-6736(13)60649-2. Epub 2013 May 2.
PubMed 23643112Noetel M, Sanders T, Gallardo-Gomez D, Taylor P, Del Pozo Cruz B, van den Hoek D, Smith JJ, Mahoney J, Spathis J, Moresi M, Pagano R, Pagano L, Vasconcellos R, Arnott H, Varley B, Parker P, Biddle S, Lonsdale C. Effect of exercise for depression: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2024 Feb 14;384:e075847. doi: 10.1136/bmj-2023-075847.
PubMed 38355154Singh B, Olds T, Curtis R, Dumuid D, Virgara R, Watson A, Szeto K, O'Connor E, Ferguson T, Eglitis E, Miatke A, Simpson CE, Maher C. Effectiveness of physical activity interventions for improving depression, anxiety and distress: an overview of systematic reviews. Br J Sports Med. 2023 Sep;57(18):1203-1209. doi: 10.1136/bjsports-2022-106195. Epub 2023 Feb 16.
PubMed 36796860Liu-Ambrose T, Li LC. Physiotherapy for Healthy Aging. Physiother Can. 2022 Jan 1;74(1):1-3. doi: 10.3138/ptc-2021-0106-gee. Epub 2022 Jan 31. No abstract available.
PubMed 35185240Rivadeneira MF, Mendieta MJ, Villavicencio J, Caicedo-Gallardo J, Buendia P. A multidimensional model of healthy ageing: proposal and evaluation of determinants based on a population survey in Ecuador. BMC Geriatr. 2021 Nov 1;21(1):615. doi: 10.1186/s12877-021-02548-5.
PubMed 34719380Johnston MC, Crilly M, Black C, Prescott GJ, Mercer SW. Defining and measuring multimorbidity: a systematic review of systematic reviews. Eur J Public Health. 2019 Feb 1;29(1):182-189. doi: 10.1093/eurpub/cky098.
PubMed 29878097
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Short-term Supervised Group Exercise Therapy, Walking and Education on Mental Health, Quality of Life and Mobility in Elderly Residents of Nursing Homes
- ClinicalTrials.gov ID
- NCT07236424
- Acronym / sponsor ID
- Studija V
- Keywords
- Mental Health, Depression, Anxiety, Quality of Life, Older Adults, Exercise Therapy, Physiotherapy, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 19 Nov 2025 (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.
Clinical Trial This clinical trial aims to determine the impact of physiotherapy interventions on mental health, quality of life, and spinal mobility in older adults. The physiotherapy intervention will consist of group exercise therapy (3 times a week, 40 minutes, 4 weeks in total), walking activities (3 times a week, 30 minutes, 4 weeks in total), and education on optimal positions and movements in daily activities (one session lasting 60 minutes)
The main questions it aims to answer are:
- Are group exercise therapy and walking optimal for reducing symptoms of depression and anxiety and improving quality of life in older adults placed in nursing homes in a short period of time
- Do physiotherapy interventions improve spinal mobility (anteflexion and extension)?
Detailed description
Population ageing is a worldwide phenomenon resulting from increased living standards, improved healthcare, and decreased birth rates. The proportion of people aged 60 and over continues to grow and is expected to exceed two billion by 2050, with 80% of them living in developed countries.
Ageing is associated with a decline in physical and mental capacities, increased risk of chronic diseases, and social isolation, leading to higher healthcare and social costs. However, many of these challenges can be prevented or mitigated through timely interventions. Global health initiatives promote Healthy and Active Ageing, focusing on maintaining longevity, well-being, and quality of life. Physical activity and exercise therapy are the most effective interventions for promoting physical and mental health, highlighting the essential role of physiotherapy. Physiotherapists are well-positioned to promote healthy ageing due to their accessibility, cost-effectiveness, and expertise in managing a wide range of health conditions. Increasing evidence shows that physiotherapy not only enhances physical function but also contributes significantly to the mental well-being of older adults.
Recent systematic reviews with meta-analyses have reported positive effects of exercise therapy and physical activity on reducing depression, anxiety, and improving quality of life among older adults. An umbrella review reports high benefits of physical activity for improving symptoms of depression, anxiety, and distress across a wide range of adult populations, including the general population, people with diagnosed mental health disorders, and people with chronic disease. A systematic review with meta-analysis confirmed exercise as an effective treatment for anxiety. However, the heterogeneity of the included studies does not provide clearer information about the optimal exercise methods, as well as the necessary parameters and ways of implementing exercise therapy. In addition, individual studies show conflicting results on the effects of physical activity in nursing home residents; one reports benefits of a structured exercise program on depressive symptoms and quality of life, while another finds no significant improvement with supervised moderate aerobic and resistance training.
Thus, this study aim is to determine the optimal methods of exercise therapy and physical activity, as well as other parameters such as frequency, intensity, supervision, and method of implementation, in improving mental health and quality of life in elderly people in a nursing home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physiotherapy22 participants |
| Control group | No intervention | –20 participants |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- both sexes, aged ≥ 65 years, with an optimal level of functional and cognitive abilities necessary to perform the exercises and understand the measurement scales.
Key exclusion criteria (1 listed)
- significant cognitive and neurological impairments, functionally immobile persons, and persons who refuse to participate.
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 |
|---|---|---|
| Physiotherapy1. Exercise therapy - stretching and breathing exercises, stabilization exercises, mobility exercises, and balance and coordination exercises. The exercises will be performed in a standing and lying position, with the possibility of using aids - gymnastic ball and resistance bands. Implementation - three times a week for 40 minutes, for a total of four weeks. 2. Walking activity - three times a week for half an hour. 3. Education on optimal positions and movement in everyday life activities - at the beginning of the study in one session lasting 60 minutes. | Behavioural | Intervention Group |
Primary outcome
Depression and Anxiety
Time frame: From enrollment to the end of treatment at 4 weeks
Hospital Anxiety and Depression Scale (0=best, 21=worst)
2 secondary outcomes
Self-reported measure of health
Time frame: From enrollment to end of the treatment at 4 weeks
Range of motion of extension and flexion in the lumbar spine
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 28110207Lok N, Lok S, Canbaz M. The effect of physical activity on depressive symptoms and quality of life among elderly nursing home residents: Randomized controlled trial. Arch Gerontol Geriatr. 2017 May-Jun;70:92-98. doi: 10.1016/j.archger.2017.01.008. Epub 2017 Jan 16.
- Background: PubMed 23643112Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther AM, Spencer A, Thorogood M, Atherton N, Bremner SA, Devine A, Diaz-Ordaz K, Ellard DR, Potter R, Spanjers K, Taylor SJ. Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial. Lancet. 2013 Jul 6;382(9886):41-9. doi: 10.1016/S0140-6736(13)60649-2. Epub 2013 May 2.
- Background: PubMed 38355154Noetel M, Sanders T, Gallardo-Gomez D, Taylor P, Del Pozo Cruz B, van den Hoek D, Smith JJ, Mahoney J, Spathis J, Moresi M, Pagano R, Pagano L, Vasconcellos R, Arnott H, Varley B, Parker P, Biddle S, Lonsdale C. Effect of exercise for depression: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2024 Feb 14;384:e075847. doi: 10.1136/bmj-2023-075847.
- Background: PubMed 36796860Singh B, Olds T, Curtis R, Dumuid D, Virgara R, Watson A, Szeto K, O'Connor E, Ferguson T, Eglitis E, Miatke A, Simpson CE, Maher C. Effectiveness of physical activity interventions for improving depression, anxiety and distress: an overview of systematic reviews. Br J Sports Med. 2023 Sep;57(18):1203-1209. doi: 10.1136/bjsports-2022-106195. Epub 2023 Feb 16.
- Background: PubMed 35185240Liu-Ambrose T, Li LC. Physiotherapy for Healthy Aging. Physiother Can. 2022 Jan 1;74(1):1-3. doi: 10.3138/ptc-2021-0106-gee. Epub 2022 Jan 31. No abstract available.
- Background: PubMed 34719380Rivadeneira MF, Mendieta MJ, Villavicencio J, Caicedo-Gallardo J, Buendia P. A multidimensional model of healthy ageing: proposal and evaluation of determinants based on a population survey in Ecuador. BMC Geriatr. 2021 Nov 1;21(1):615. doi: 10.1186/s12877-021-02548-5.
- Background: PubMed 29878097Johnston MC, Crilly M, Black C, Prescott GJ, Mercer SW. Defining and measuring multimorbidity: a systematic review of systematic reviews. Eur J Public Health. 2019 Feb 1;29(1):182-189. doi: 10.1093/eurpub/cky098.
- Individual participant dataSharing planned: Yes
Related trials for Mental Health Care
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Bringing Health Home
Mental Disorders, Severe
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Mental Health Care and Depression Anxiety Disorder, run by University of Mostar at 1 site in Bosnia and Herzegovina.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression and Anxiety (time frame: From enrollment to the end of treatment at 4 weeks). 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 NCT07236424, which also lists 7 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 12 Jan 2026.