Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000046303
Ethics application status
Approved
Date submitted
21/11/2016
Date registered
10/01/2017
Date last updated
10/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of various form of nordic walking training on functional fitness and quality of life in the women over 60 years old.
Scientific title
The influence of various form of nordic walking training on functional fitness and quality of life in the women over 60 years old.
Secondary ID [1] 290588 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
functional fitness 301048 0
quality of life 301049 0
Condition category
Condition code
Musculoskeletal 300837 300837 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Examine intervention will be our original nordic walking training program. Examine program will be realised for 8 weeks with frequency of twice per week. Each session will last 1 hour and it will took place outside in a city park. The training will consist of walking and a large amount of exercises with poles as a useful gym equipment. The sequence parts of the training: 1.warming up (10 minutes), 2. nordic walking (10 minutes), 3. central part (20 minutes), 4. nordic walking (10 minutes), 5. cooling down (10 minutes). Exercises with poles will be conducted during the warming up, in the central part of session and finally cooling down. During warming up and cooling down it will be only individual exercises with poles, but central part of session will be consist of a large amount of exercises with poles. It will be individual exercises, exercises in pairs and exercises on the obstacle course. It will be strengthening, stretching, breathing and balance exercises. In addition it will be exercises improve reaction time. We designed these all exercises especially for elderly to improve their physical fitness and daily functioning. The intensity of these sessions will be between 14-16/20 RPE scale. Trainings will be conducted in groups up to 10 people. Training will be conducted by a qualified Instructor Nordic Walking, who is also Master of Physiotherapy. In addition during trainings will always be at least 2 extra person (from the reaserch group) to assist in the safe conduct of trainings and monitoring of participants We will register of attendance at session. Regarding to recruting to 3 groups, we first will recruite people to experimental group, then to comparator group and finally to control group. Each subject will be examined two times: at baseline - prior to training program and immediately after 8 weeks program.
Intervention code [1] 296451 0
Treatment: Other
Comparator / control treatment
Control intervention will be standard nordic walking training program. It will be realised for 8 weeks with frequency of twice per week. Each session will last 1 hour and it will took place outside in a city park. The training will consist only of nordic walking and short warming up and cooling down phases. The sequence parts of the training: 1 warming up (5 minutes), 2. nordic walking (50 minutes), 3. cooling down (5 minutes). Trainings will be conducted in groups up to 10 people. The intensity of these sessions will be between 14-16/20 RPE scale. Trainings will be conducted by a qualified Instructor Nordic Walking who is also Master of Physiotherapy. In addition during trainings will always be at least 2 extra person (from the reaserch group) to assist in the safe conduct of trainings and monitoring of participants. We will register of attendance at session. Each subject will be examined two times: at baseline - prior to training program and immediately after 8 weeks program.
Control group
Active

Outcomes
Primary outcome [1] 300254 0
Influence of our original nordic walking program on functional fitness. Functional fitness will be assessed by Senior Fitness Test, Tinetti Performance Oriented Mobility Assessment, Timed Up and Go Test, Functional Reach Test.
Timepoint [1] 300254 0
Baseline and after 8 weeks training program.
Primary outcome [2] 300255 0
Influence of our original nordic walking program on quality of life. Qualty of life will be assessed by questionnaire for quality of life assessment sf-36 v.1.
Timepoint [2] 300255 0
Baseline and after 8 weeks training program.
Secondary outcome [1] 329504 0
Influence of our original nordic walking program on fear of falling. Fear of falling will be assessed by Visual Analog Scale.
Timepoint [1] 329504 0
Baseline and after 8 weeks training program.

Eligibility
Key inclusion criteria
women over 60 years old
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women with diseases significantly interfering with locomotion,
women with dementia (a result of Mini–Mental State Examination under 24 points),
women participate in other training program of physiotherapy treatment during training period,

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 8406 0
Poland
State/province [1] 8406 0

Funding & Sponsors
Funding source category [1] 295014 0
University
Name [1] 295014 0
University of Physical Education in Krakow
Country [1] 295014 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 293834 0
None
Name [1] 293834 0
Address [1] 293834 0
Country [1] 293834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296369 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 296369 0
ul. Krupnicza 11a, 31-123 Krakow, Poland
Ethics committee country [1] 296369 0
Poland
Date submitted for ethics approval [1] 296369 0
Approval date [1] 296369 0
15/04/2015
Ethics approval number [1] 296369 0
44/KBL/OIL/2015

Summary
Brief summary
One of the new challenges in modern medicine and rehabilitation is providing care for the elderly. Many of them have multiple diseases which lead to reduction of physical fitness. Particurarly important in daily activity are walking efforts to support and develop all component of physical fitness. Nordic walking is kind of walking with the use of specially designed poles. In addiction we think that pole are very useful gym equipment for elderly exercises. It can be individual exercises, exercises in pairs and exercises on the obstacle course. These kind of exercises with use poles can improves strength and flexibility of the upper and lower body, coordination complex, balance, gait, performance of activitiesof daily living, independence and quality of life. We believe that elderly can achieve greater effect on functional fitness from exercises with use poles as a useful gym equipment than only from walking with poles. Besides, these exercises are very safe for elderly. The aim of this study is evaluate the impact of various form of nordic walking training program on functional fitness and quality of life in the women over 60 years old. Especially we want to check if training with a large amount of exercises with use poles as a gym eqipment is better than a standar training based only on the walking with poles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70638 0
Prof Marek Zak
Address 70638 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 70638 0
Poland
Phone 70638 0
+48 666042053
Fax 70638 0
Email 70638 0
[email protected]
Contact person for public queries
Name 70639 0
Prof Marek Zak
Address 70639 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 70639 0
Poland
Phone 70639 0
+48 666042053
Fax 70639 0
Email 70639 0
[email protected]
Contact person for scientific queries
Name 70640 0
Prof Marek Zak
Address 70640 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 70640 0
Poland
Phone 70640 0
+48 666042053
Fax 70640 0
Email 70640 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4036Plain language summaryNo Comparison of the differences between the results ... [More Details]
4639Conference abstractNo

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