Home » Trials » SLCTR/2016/004
The influence of three months of physical exercises and verbal stimulation on functional efficiency and the ways elderly people spend their free time under institutional care – a randomized controlled study.
-
SLCTR Registration Number
SLCTR/2016/004
Date of Registration
The date of last modification
Aug 26, 2022
Trial Status
Scientific Title of Trial
The influence of three months of physical exercises and verbal stimulation on functional efficiency and the ways elderly people spend their free time under institutional care – a randomized controlled study.
Public Title of Trial
The impact of regular physical activity and verbal stimulation on functional efficiency and the ways elderly people spend their free time under institutional care – a randomized controlled study.
Disease or Health Condition(s) Studied
Health Problems
Scientific Acronym
None
Public Acronym
None
Brief title
The impact of regular physical activity and verbal stimulation on functional efficiency and the ways elderly people spend their free time under institutional care.
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC: 6/06/2015, University of Rzeszow
What is the research question being addressed?
What is the degree of improvement in functional performance and the possibility of changing habitual ways of spending free time among elderly people under institutional care by applying physical training with stimulation?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 4
Intervention(s) planned
The subjects will be recruited from nursing homes for the elderly.
The subjects will be assigned at random to one of four groups:
Arm 1: basic exercises combined with verbal stimulation.
Arm 2: basic exercises without verbal stimulation.
Arm 3: functional exercises training with verbal stimulation.
Arm 4: functional exercises training without verbal stimulation.
Study I – preliminary tests. Study II – after the end of intervention. Study III – 12 weeks after the end of intervention. Study IV – 24 weeks after the end of intervention.
The exercise programme:
Basic exercises: The programme includes exercises performed in a sitting position containing elements of aerobic, stretching and equivalent exercise.
Functional exercises programme: Training will be divided into two sessions: Session I: strengthening and stretching training – exercises performed in a sitting position using a Thera-Band and gymnastic sticks.
Session II: equivalent and functional training – exercises performed in a seated and standing position with use of chairs as aids to stabilize position, and containing complex movements which older people perform in everyday activity.
Frequency of training: twice a week for 30 minutes. Intensity of effort on the Borg scale: 11–13 points. Before and after each workout, blood pressure is taken and heart rate is noted. The exercises will be held in groups of four to eight in a nursing home, and will be conducted by a qualified physiotherapist.
Verbal stimulation: this is assumed to enhance the motivation of elderly people to undertake physical activity. Participants will be motivated by presenting the exercise strategy and objectives and by asking about the subjective possibilities of physical exertion and achieving particular goals.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Timed Up-and-Go Test, 10-Metre-Walk Test |
[ Timepoint: at baseline and at 12, 24, and 36 weeks after commencement of intervention. ] |
|
2.
Back Scratch, Chair Sit and Reach. |
[ Timepoint: at baseline and at 12, 24, and 36 weeks after commencement of intervention. ] |
|
3.
Berg Balance Scale |
[ Timepoint: at baseline and at 12, 24, and 36 weeks after commencement of intervention. ] |
|
4.
Physical Activity Scale for Elderly |
[ Timepoint: at baseline and at 12, 24, and 36 weeks after commencement of intervention. ] |
Secondary outcome(s)
|
1.
Grip strength (JAMAR+) |
[ Timepoint: at baseline and at 12, 24, and 36 weeks after commencement of intervention. ] |
|
2.
Short Physical Performance Battery |
[ Timepoint: at baseline and at 12, 24, and 36 weeks after commencement of intervention. ] |
Target number/sample size
156 people. The sample size was chosen according to Cohen using standardly used assumptions: 0.05 severity level, power of test 0.8, 0.5 effect size, Cohen effect of the average.
Countries of recruitment
Poland
Anticipated start date
2016-03-01
Anticipated end date
2016-05-05
Date of first enrollment
2016-03-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Statutory activity – grants from the Ministry of Science and Higher Education University of Rzeszow Ul. Rejtana 16C 35-959 Rzeszow, Poland
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2015-06-02
Approval number
6/06/2015
Details of Ethics Review Committee
| Name: | Bioethics Committee University of Rzeszow Institute of Physiotherapy University of Rzeszow |
| Institutional Address: | Warszawska 26A Street, 35-205 Rzeszow, Poland |
| Telephone: | +017-8721920 |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Agnieszka Cwirlej-Sozanska
Doctor of Medicine
Institute of Physiotherapy
University of Rzeszow,
Warszawska 26A Street,
35-205 Rzeszow, Poland
+ 48 (17) 872 19 20
+48 530 172 857
sozanska@univ.rzeszow.pl
Contact Person for Public Queries
Agnieszka Wisniowska
Doctor of Health Science
Institute of Health Sciences
Medical College of Rzeszow University, Warzywna 1A Street, 35-310 Rzeszow
+ 48 (17) 872 19 20
+48 604 181 162
wisniowska@vp.pl
Primary study sponsor/organization
Statutory activity – grants from the Ministry of Science and Higher Education
University of Rzeszow
Ul. Rejtana 16C
35-959 Rzeszow, Poland
+ 48 (17) 872 19 20
ifizjot@univ.rzeszow.pl
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Yes
Protocol version and date
Results summary available
No
Date of posting results
Date of study completion
Final sample size
162
Date of first publication
Link to results
Brief summary of results
In the group with functional exercise training with verbal stimulation, in comparison to the group with basic exercises, the greatest positive short-term impact of intervention was demonstrated in terms of functional fitness (increased by 1.31 points; 95% confidence interval (CI) = 0.93–1.70), gait speed (improved by 0.17 m/s, 95% CI = 0.13–0.22), hand grip strength (by over 4 kg; 95% CI = 2.51–4.95), and upper-limb flexibility (by 10 cm; 95% CI = 5.82–12.65). There was also a significant increase in the level of free-time physical activity and an improvement in the quality of life, especially as expressed in the domain of overall physical functioning. Our study showed that a functional exercise program, combined with verbal stimulation, is effective at improving physical fitness and raising the level of free-time physical activity.
