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Comparison of the influence of a 12-week physical exercise program with elements of dance movement therapy versus standard treatment on, upper limb physical performance and quality of life of elder people using wheelchairs and being under institutional care – randomized controlled trial -

SLCTR Registration Number

SLCTR/2018/014


Date of Registration

16 May 2018

The date of last modification

Jun 05, 2018



Application Summary


Scientific Title of Trial

Comparison of the influence of a 12-week physical exercise program with elements of dance movement therapy versus standard treatment on, upper limb physical performance and quality of life of elder people using wheelchairs and being under institutional care – randomized controlled trial


Public Title of Trial

Impact of physical activity and dance movement therapy on dexterity and life quality of nursing home inhabitants using wheelchairs – randomized controlled trial


Disease of Health Condition(s) Studied

Rehabilitation


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

ERC: 2017/11/09, University of Rzeszow


Trial Details


What is the research question being addressed?

What is the degree of improvement in upper limb physical performance and quality of living in elder people using wheelchairs and being under institutional care after a physical exercise program with elements of dance movement therapy


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Health services research


Purpose

Phase 3


Intervention(s) planned

The subjects will be assigned randomly to one of three groups: Group 1: Basic exercises Group 2: Movement exercises with elements of dance movement therapy: Group 3: No Intervention: control, routine care

Randomization will be carried out by stratified sampling. To obtain an equal distribution of senior subjects across the study groups, the allocation will be performed as block randomization. We will use four-in-one blocks. To solve the problem of predicting the next assignment, the allocator will hide the block size from the executer and use randomly mixed block sizes.

The exercise programme: The exercises will be held in groups of five to eight in nursing homes located in South-Eastern Poland, in rooms suitable for people on wheelchairs, and will be conducted by qualified physiotherapists. The program for each group consists of 30-minute session, two times a week, 12 weeks total. Intensity of effort on the Borg scale: 11–13 points. Before and after each workout, blood pressure and heart rate is measured and noted. The intervention is considered accomplished if the patient takes part in at least 80% of entire exercise program. An attendance of participants will be checked. Group 1: Basic exercises: The program includes exercises performed on wheelchairs and containing elements of active, stretching and balance exercises. The exercises will be performed in following scheme: Warm-up (10 minutes): simple exercises focused on upper part of the body, arms rotation, flexing arm and elbow joints, wrists turning, hands closing and opening, bending and unbending the body. Main part (15 minutes): slow active exercises, flexibility and balance exercises Cool-down (5 minutes): muscle-relaxing and calming exercises for lowering the heart rate. Stretching exercises for increasing joint motillity in upper limbs Group 2: Movement exercises with elements of dancing: The program includes exercises performed on wheelchairs. The exercises will be performed in following scheme: Warm-up (5 minutes): The person conducting the exercises starts session with the rythmic hand clapping to the background music. The participants will follow the physiotherapist and simulate activities and phenomenas like driving the car, rustling trees, collecting fruits, etc to prepare the muscles of upper body part. Main part (20 minutes): dance-movement exercises. This phase consists of simple, easy to repeat moves performed in sitting position (on a wheelchair). The physiotherapist will demonstrate a sequence of moves without music and then the group will be repeating the sequence with carefully selected and prepared music such as cha-cha, zumba, jive, macarena, hula dance, etc. The example sequence may contain following moves: hands clapping, wrists turning, arms and body waving. Moreover, gymnastic accessories like sticks, dumb-bells, balls, elastic bands (Thera-bands) will be used. Each exercise program will contain strengthening and balance exercises. The music will be changed each week for six week and then repeated through another six weeks. The character and tempo of the music samples used during sessions will be matched for perceptive and mobility capabilities of the elder people. At the end of the main part, the patients will be asked to perform spontaneous motive improvisation to stimulate imagination, creativity and self-expression. Interactions between subjects will serve to improve communication and social skills. Cool-down (5 minutes): simple stretching and breathing exercises on a background of peaceful and relaxing music. After physical activity the therapist will initiate a short discussion on feelings and impressions after exercise session. Group 3: No Intervention: control routine care The data of the control group will be collected simultaneously to the intervention groups. The subjects in the control group will also be advised to avoid physical activity for 12 weeks. During an interview after 12 weeks of data collection, any subject who states that he/she has started a regular physical activity of any type will be excluded from the control group. The subjects from the control group will be offered an attendance in physical exercise program after the intervention.


Inclusion criteria

  1. Residents of nursing homes for the elderly and people with chronic illness.
  2. Wheelchair-bound seniors BBS 4 < 21 pts
  3. Aged 65–85.
  4. Barthel Index 21 <75 pts
  5. MMSE >19 pts
  6. GDS < 10 pts.

BBS- Berg Balance Scale Assessment of static and dynamic balance based on 14 types of movement in the standing and sitting position of the patient. Each task of the test is scored using a four-point scale. A maximum score of 56 points is possible. Patients with a score below 20 pts indicate high risk of fall and need of using wheelchairs.

Barthel Index is a scale for ADL (Activities of Daily Living) measurement, with lower scores indicating greater dependency in ADL. The score value ranges between 0 and 100 points. The assessment of the total score is as follows: 0–20 completely dependent; 21–61 almost completely dependent; 62–85 dependent; 91–100 – independent

The Mini–Mental State Examination (MMSE), is a brief, quantitative measure of cognitive status of adults. It can be used to screen the cognitive impairment. The score is the number of correct items. The measure yields a total score of 30. A score of 30-24 means no cognitive impairment , 23-19 pts - mild cognitive impairment, 18 or less is the severe cognitive impairment.

The Geriatric Depression Scale (GDS) is a 15-item self-report assessment used to identify depression in the elderly. Scores of 0-5 are considered normal; 6-10 indicate moderate depression; and 11-15 indicate severe depression.


Exclusion criteria

  1. Having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
  2. Suffering from spinal cord injury with no rehabilitation potential
  3. Lack of consent of elderly person or their doctor for participation in exercises.


Primary outcome(s)

  1. Grip strength

Grip Strength will be assessed using a dynamometer (JAMAR PLUS+Hydraulic Hand Dynamometer, Patterson Medical)


Primary outcome(s) - Time of assessment(s)

At baseline, at 12 weeks and at 24 weeks after commencement of intervention.


Secondary outcome

  1. Quality of life –SF-36
  2. Body Flexibility: Upper Body Flexibility Back Scratch Test, Lower Body Flexibility Chair Sit-and-Reach Test
  3. Index Barthel
  4. Lung Capacity TruZoneTM Peak Flow Meter
  5. Range of the Joint's Motion (shoulders, elboves)
  6. Manual upper limb movement Box and Block
  7. Curl arm 30sek
  8. Geriatric Depression Scale GDS 15

The 36-Item Short Form Health Survey (SF-36) is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public. SF-36 includes one multi-item scale measuring each of eight health concepts: 1) physical functioning; 2) role limitations because of physical health problems; 3) bodily pain; 4) social functioning; 5) general mental health (psychological distress and psychological well-being); 6) role limitations because of emotional problems; 7) vitality (energy/fatigue); and 8) general health perceptions.

Body Flexibility: Upper Body Flexibility, The Back Stretch (BS) test is used to assess flexibility of the upper limbs. It will be carried out in a standing position. The participants will be directed to take one hand up and over the shoulder and reach down the back, and the other hand behind and reaching up the back, with the intention of meeting the hands in the middle of the back, between the shoulder blades. Flexibility will be determined as the distance (in centimeters) between the middle fingers Lower Body Flexibility Chair The Chair Sit and Reach (CSR) test is used to assess flexibility of the lower limbs. From the sitting position, the participant will be directed to use two hands to reach forward towards the flexed toes of the extended leg. Flexibility will be determined as the distance (in centimeters) between the toes on the flexed foot of the extended leg and the fingers of the hands. Arm Curl Test - the 30 sec single-arm curl test, a measure of upper-body strength and endurance, determines the number of times a dumbbell (5 lb, or 2.3 kg, for women and 8 lb, or 3.6 kg, for men) can be curled through a full ROM (Range of Motion) in 30 sec.

The Box and Block Test (BBT)- is tool for examining upper-limb function. In the BBT, one hundred and fifty 2.5ccm wooden blocks in many different orientations are placed on the side of the partition with the testing hand. A subject’s score is equal to the number of these blocks transported over a partition in one minute. The subject can select blocks in any order to transport over the partition as quickly as possible, with the only requirement being that the subject’s fingertips cross the vertical plane of the partition.

Lung Capacity will be measured by Peak Flow Meter. Participants take a deep breath and blow air into the meter as fast as they can.

Range of Motion for flexion, abduction and rotation shoulder and elbow dominant side using goniometer.


Secondary outcome(s) - Time of assessment(s)

At baseline and at 12 and 24weeks after commencement of intervention.



Target number/sample size

150 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

2018-06-01


Anticipated end date

2019-02-01


Recruitment status

Pending


State of ethics review approval

Bioethics Committee University of Rzeszow Institute of Physiotherapy University of Rzeszow, Warszawska 26A Street, 35-205 Rzeszow, Poland The Ethics Commission’s consent was obtained on 9 November 2017. Number consent of the 2017/11/09.


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Agnieszka Wisniowska-Szurlej
Doctor of Health Science
Institute of Physiotherapy University of Rzeszow, Warszawska 26A Street, 35-205 Rzeszow, Poland
+ 48 (17) 872 19 20


wisniowska@vp.pl

Contact Person for Public Queries

Natalia Woloszyn
Master
Institute of Physiotherapy University of Rzeszow, Warszawska 26A Street, 35-205 Rzeszow, Poland
+ 48 (17) 872 19 20


natalia.woloszyn@op.pl


Primary study sponsor/organization

University of Rzeszow

University of Rzeszow Ul. Rejtana 16C 35-959 Rzeszow, Poland
+ 48 (17) 872 19 20

ifizjot@univ.rzeszow.pl

Secondary study sponsor (If any)