- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236424
Effectiveness of Exercise, Walking, and Education on Mental Health, Mobility and Quality of Life in Elderly Residents of Nursing Homes
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)?
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Žepče, Bosnia and Herzegovina, 72230
- Nursing home "Ministro", Žepče
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- both sexes, aged ≥ 65 years, with an optimal level of functional and cognitive abilities necessary to perform the exercises and understand the measurement scales.
Exclusion Criteria:
- significant cognitive and neurological impairments, functionally immobile persons, and persons who refuse to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
22 participants
|
|
|
No Intervention: Control group
20 participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression and Anxiety
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Hospital Anxiety and Depression Scale (0=best, 21=worst)
|
From enrollment to the end of treatment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported measure of health
Time Frame: From enrollment to end of the treatment at 4 weeks
|
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)
|
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
|
Goniometer (extension 0-40°, flexion 0-70°; higher score best)
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Singh 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.
- Underwood 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.
- Noetel 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.
- Liu-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.
- Rivadeneira 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.
- Johnston 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Studija V
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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