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.

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SLCTR Registration Number

SLCTR/2016/004


Date of Registration

12 Feb 2016

The date of last modification

Jan 29, 2019



Application Summary


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


Trial Details


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

  1. Residents of nursing homes for the elderly and people with chronic illness.
  2. Aged 65–85.
  3. MMSE >19.
  4. GDS < 20 pkt.
  5. Spending free time sitting at least four hours a day / six to seven days a week.

Exclusion criteria

  1. Severe systemic disease.
  2. Severe circulatory or organic insufficiency.
  3. Severe neurological disorder.
  4. Lack of consent of elderly person or their doctor for participation in exercises.


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

Recruiting


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



State of Ethics Review Approval


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 & Sponsor Information


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
Master
Institute of Physiotherapy University of Rzeszow, Warszawska 26A Street, 35-205 Rzeszow, Poland
+ 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

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results