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Trial registered on ANZCTR


Registration number
ACTRN12618000532202
Ethics application status
Approved
Date submitted
31/01/2018
Date registered
10/04/2018
Date last updated
10/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effect of physiotherapy group education on quality of life, physical performance and back muscle strength among postmenopausal women with osteoporosis.

.
Scientific title
Effectiveness of Physiotherapeutic Group Education in Improving Quality of Life, Physical Performance and Back Extensor Muscle Strength among Postmenopausal Women with Osteoporosis
Secondary ID [1] 294279 0
UKM PPI/118/JEP-2016-6580)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoporosis 306134 0
Condition category
Condition code
Musculoskeletal 305249 305249 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An experienced (15 years) physiotherapist was conducted group education and exercises for a group of 15 participants.
One hour of physiotherapeutic group education regarding of facts about osteoporosis,falls prevention and home exercise program which included demonstration and a trial of the exercises prescribed.

A booklet name “Guidelines for exercises and physical activity for adults at risk of osteoporosis” is designed specifically for this study. This booklet was provided as a reference for the participants to continue their home exercise program.

Example of home exercises prescribed.

Warming exercise
Shoulder rotate backwards for 2-5 minutes
Marching in place for 2-5 minutes

Stretching exercise
Shoulder stretch:
bring one arm back over the spine while using the other arm to stretch backwards gradually., Hold for 10 seconds.

Calf stretching:
standing place one foot forward: bend the front leg and keep the back leg flat on the floor, pointing forward. Hold for 10 seconds.

Resistance training with weight (1/2-4kg, dumbbell or sandbag for leg or theraband)
Overhead shoulder lift: Sitting, hold a dumbbell (1/2- 4 kg) in each hand at shoulder level. Lift the dumbbells overhead (upward) by extending the arms. Lower the dumbbells with flex the arm back to initial position.

Lower limbs: Sitting, strapped one leg with theraband or weight (1/2-4 kg) around the ankle. Straighten the knee and hold for 10 seconds, then return to original position.

Repeat with the other leg

Balance exercises
Tandem standing with hold onto the chair, hold for 10 seconds, repeat with the other leg

Single leg standing with hold onto the chair hold for 10 seconds, repeat with another leg

Postural correction and flexibility exercises
‘Chin Tuck in’ in sitting, hold for 10 seconds.

Backward stretch: sitting raise both arms to side with elbow, hold for 10 seconds at should level

8-week home exercise program with the mode of administration, 30 minutes of exercise session consisted of a 5 minute of warm-up, 20 minutes of back strengthening, balance, and postural corrections, and 5 minutes of cool down exercise.

The exercises designed is based on frequency, intensity, time and type (F.I.T.T. Principle)
Frequency: 3 times /week.
Intensity: 5-8 repetitions, 3 sets for each exercise.
Time :30-60 minutes /day
The exercises were progressed by increasing the number of repetitions and sets with gradually increased resistance.
Target intensity of exercises is at participants discretion.

Participants were required to record the exercises performed in an exercise diary that was provided.
Participants were contacted every two weeks to review compliance and advice were provided if participants had any concerns.
Intervention code [1] 300004 0
Rehabilitation
Comparator / control treatment
Control group
Participants in the control group continued their usual care and activities without any restriction until the end of the study (8 weeks) and post-intervention measurements. After which, the participants were provided with the intervention that was received by the intervention group.

Usual care is referred to physical activities (e.g. brisk walking, jogging or Tai Chi, stretching exercises) have been carried out by participants as usual w participants without limitation.
Control group
Active

Outcomes
Primary outcome [1] 304402 0
Back extensor muscle strength (BEM) was measured using load cell
Timepoint [1] 304402 0
at baseline of group education session and
8 weeks post- group education session
Secondary outcome [1] 341833 0
.Quality of life measured by Euro-EQ5D Questionnaire (EQ5DVAS and EQ-5D)
Timepoint [1] 341833 0
at baseline of group education session and
8 weeks post- group education session
Secondary outcome [2] 344622 0
Physical function measured by Short Physical Performance Battery (SPBB)
Timepoint [2] 344622 0
at baseline of group education session and
8 weeks post- group education session
Secondary outcome [3] 344623 0
Dominant hand grip strength measured by hand-held hydraulic dynamometer (Jamar),
Timepoint [3] 344623 0
at baseline of group education session and
8 weeks post- group education session
Secondary outcome [4] 344624 0
Risk and Fear of Falls measured by Activities-Specific Balance Confidence
Timepoint [4] 344624 0
at baseline of group education session and
8 weeks post- group education session

Eligibility
Key inclusion criteria
(1) postmenopausal women aged 55 years and above;
(2) not having physiotherapy currently;
(3) ambulating without walking aids.
Minimum age
55 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) had chronic back pain with Visual Analogue Scale (VAS) more than 5;
(2) prior surgery to the back;
(3) experienced serious trauma that led to fractures and dislocations at the spine;
(4) had any known underlying pathologies such as tumour, spinal infections, tuberculosis, inflammatory joint diseases and other rheumatological conditions;
(5) had unstable cardiovascular and respiratory conditions that limit participation in the intervention.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A participant who was eligible for inclusion in the trial was allocated randomly into intervention and control group by central randomisation using a computer system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number table :
Randomization was done a few times until the two groups matched for age, body mass index and baseline measurements.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For baseline measurements, Shapiro-Wilk test was used to determine the normality of sample distribution. Independent t-test and Mann-Whitney test were used to compare the experimental and control groups at baseline for continuous data while Chi-square test was used for nominal data. Data was analyzed using intention-to-treat analysis, where the baseline data was used irrespective of the lost to follow up after the intervention. A mixed model ANOVA was used to examine the effectiveness of physiotherapeutic group education post 8th weeks in terms of time, group and interaction effect. The significant level was set at p < 0.05 for each statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
30/04/2017
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
30
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 9479 0
Malaysia
State/province [1] 9479 0
Selangor

Funding & Sponsors
Funding source category [1] 298363 0
University
Name [1] 298363 0
Universiti Kebangsaan Malaysia
Country [1] 298363 0
Malaysia
Primary sponsor type
Government body
Name
Ministry of Higher Education, Malaysia
Address
Jalan P5/6, Presint 5,
62200 Putrajaya,
Wilayah Persekutuan Putrajaya
Country
Malaysia
Secondary sponsor category [1] 297488 0
None
Name [1] 297488 0
Nil
Address [1] 297488 0
Nil
Country [1] 297488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299359 0
Research Ethics Committee, Universiti Kebangsaan Malaysia
Ethics committee address [1] 299359 0
Ethics committee country [1] 299359 0
Malaysia
Date submitted for ethics approval [1] 299359 0
16/10/2016
Approval date [1] 299359 0
16/01/2017
Ethics approval number [1] 299359 0
Ref. No. UKM NN-2017-019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80170 0
A/Prof Devinder Kaur Ajit Singh
Address 80170 0
School of Rehabilitation Sciences,
Faculty of Health Sciences,
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur,
Country 80170 0
Malaysia
Phone 80170 0
+60-03-26878037
Fax 80170 0
+60-03-26878199
Email 80170 0
devinder@ukm.edu.my
Contact person for public queries
Name 80171 0
Devinder Kaur Ajit Singh
Address 80171 0
School of Rehabilitation Sciences,
Faculty of Health Sciences,
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur,
Country 80171 0
Malaysia
Phone 80171 0
+60-03-26878037
Fax 80171 0
+60-03-26878199
Email 80171 0
devinder@ukm.edu.my
Contact person for scientific queries
Name 80172 0
Devinder Kaur Ajit Singh
Address 80172 0
School of Rehabilitation Sciences,
Faculty of Health Sciences,
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur,
Country 80172 0
Malaysia
Phone 80172 0
+60-03-26878037
Fax 80172 0
+60-03-26878199
Email 80172 0
devinder@ukm.edu.my

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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