Sedentary LifestylePole walkingNCT03096964

Nordic Walking Training for Older People

A study testing Free walking training and Nordic walking training in people with Sedentary Lifestyle and Age Problems, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle, Age Problems
What is being tested?: Free walking training and Nordic walking training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteBrazil
Study dates: Mar 2014to Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Sedentary elderly people
Aged between 60 and 80

Who cannot join

Smoking
Show chronic pain or presence of migraine or nausea in daily life;
History of labyrinthitis

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

Official title: Effects of Nordic Walking Training in Energetic, Mechanical and Neuromuscular Parameters of Elderly. A Randomized Clinical Trail

Objective: to assess by means of a randomized clinical trial the effects of eight weeks of Nordic walking and free walking training on quality of life (QoL), static balance, dynamic variability, self-selected walking speed (SWS) and locomotor rehabilitation index (LRI), parameters of pendular mechanism [external (Wext), internal (Wint) and total mechanical work (Wtot), Recovery (R), Cost of Transport (C)], Electromyographic parameters (Average signal and co-contraction of the Anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) muscles, heart rate of exercise (HRexercise) - and the rate of perceived exertion (RPE), in sedentary elderly.

Read the detailed description

Introduction: Considering the increase in the elderly population and their life expectancy, together with the expansion of Nordic walking (NW) interventions as a training method for the elderly, there is a need of preventive studies of RCTs and with methodological good quality approach to enable physical education, health and rehabilitation professionals to make decisions regarding the type, the volume and the intensity of NW exercise in promoting the health of the sedentary elderly. Objectives: The aim of this study is to evaluate, through a randomized clinical trial, the effects of eight weeks of NW and FW training on quality of life (QoL), static balance, dynamic variability, self-selected treadmill walking speed (SSWSTreadmill), Locomotor rehabilitation (LRI) Parameters of Pendular Mechanism (external, internal and total mechanical work -Wext, Wint, Wtot, Recovery -R,Cost of Transport - C), Electromyographic parameters (Average signal and co-contraction of the AD, TB, VL, BF, AT and MG muscles), heart rate of exercise - HRexercise and the rate of perceived exertion (RPE), in sedentary elderly. of sedentary elderly. Experimental Design: Randomized Controlled Clinical Trial (RCT). Study Site: School of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 sedentary participants randomly divided into two groups (Nordic walking group and Free walking group who will perform training for 8 weeks.

Conditions: Sedentary Lifestyle, Age Problems
Being tested: Free walking training, Nordic walking training
Keywords: Elderly training, Pole walking, Locomotor Rehabilitation Index, Self-selected speed of walking, Recovery
Medical subject headings: Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Free walking trainingOther
The training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.
Nordic walking trainingOther
The training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.

Study groups in NCT03096964
Study group	Role	What they receive
Nordic walking	Experimental	Experimental: Nordic walking Training The total period of training was composed by 8-week of walking with poles, three sessions per week. The cycles were divided into eight microcycles composed by three training sessions. Each training session took 60 min. Nordic walking aerobics training were used during the training period. These exercises were performed alternating volume and intensity. Exercise intensities were controlled using the cardiac monitor, and the zone was since 70% to 105% of the heart rate at the second ventilatory threshold. And volume was controlled using the time of the session. Receives: Other: Nordic walking training
Free Walking	Experimental	Experimental: Free walking Training The total period of training was composed by a 8-week cycles of walking without poles, with three sessions per week. The cycles were divided into eight microcycles composed by three training sessions. Each training session took 60 min. Free walking aerobics training were used during the training period. These exercises were performed alternating volume and intensity. Exercise intensities were controlled using the cardiac monitor, and the zone was since 70% to 105% of the heart rate at the second ventilatory threshold. And volume was controlled using the time of the session. Receives: Other: Free walking training

What is being measured

The primary outcome is the main question the study is designed to answer.

Self-selected walking speed - SSWS
This outcome will be measure through sub-maximal test of walking treadmill, using the portable gas analyser Equipment.
Measured: Change from baseline SSWS at 8 weeks

Secondary outcomes (20)

Quality of life (QoL)
The quality of life will be estimated using the World Health Organization Quality of Life Project for elderly people (WHOQOL) instrument.
Measured: Change from baseline QoL at 8 weeks
Locomotor rehabilitation index (LRI)
This outcome will be measure through of the measure on sub-maximal test of walking treadmill, using the three-dimensional motion analysis system (VICON).
Measured: Change from baseline LRI at 8 weeks
Oxygen consumption (VO2)
This outcome will be measure through of the of the walking test on treadmill and too using the portable gas analyzer equipment (units in ml/kg/min).
Measured: from baseline to 8 weeks
Cost of transport (C)
This outcome will be measured through of the walking test on a treadmill will be collected the oxigem consumption using the portable gas analyzer equipment (measure unit in ml.O2.km).
Measured: from baseline to 8 weeks
Optimal Walking Speed (OPT)
This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill (unit in km/h)
Measured: from baseline to 8 weeks
Oxygen Consumption at anaerobic threshold (VO2VT2)
This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
Measured: from baseline to 8 weeks
Peak Oxygen Consumption (VO2peak)
This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
Measured: from baseline to 8 weeks
Heart Rate at anaerobic threshold (HRVT2)
This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1).
Measured: from baseline to 8 weeks
Rest Heart Rate (HRrest)
This outcome will be measure using a heart rate monitor (POLAR, FT1). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the heart rate.
Measured: from baseline to 8 weeks
Exercise Heart Rate (HRexercise)
This outcome will be measure using a heart rate monitor (POLAR, FT1) measurement of the heart rate of exercise during the walking test on treadmill at different speed.
Measured: from baseline to 8 weeks
Rest Arterial Systolic Blood Pressure (SBPrest)
This outcome will be measured through blood pressure ambulatory monitor (Meditech). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the arterial systolic blood pressure.
Measured: from baseline to 8 weeks
Rest Arterial Diastolic Blood Pressure (DBPrest)
This outcome will be measured through blood pressure ambulatory monitor (Meditech, ABPM-04 equipment). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the arterial systolic blood pressure.
Measured: Change from baseline DBPrest at 8 weeks
Parameters of Static balance (Amplitude ans Speed of Center of pressure in X, Y and Z axis)
This outcome will be measure through of Static Balance in Force Platform (AMTI)
Measured: Change from baseline Parameters of Static Balance at 8 weeks
Parameters of Dynamic variability (coefficient of variation (CoV) of Stride length (SL), stride frequency (SF), swing time (ST), and contact time (CT)
This outcome will be measure through of the variability on sub-maximal test of walking treadmill, using the three-dimensional motion analysis system (VICON).
Measured: Change from baseline Parameters of Dynamic Balance at 8 weeks
Spatial Temporal Parameters (stride frequency, stride length, swing time and contact time)
This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
Measured: Change from baseline Spatial Temporal parameters at 8 weeks
Parameters of Pendular Mechanism (external, internal and total mechanical work, Wext, Wint and Wtot, respectively, Recovery).
This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
Measured: Change from baseline Parameters of Mechanical Work at 8 weeks
Other Parameters of Pendular Mechanism (Percentage of congruity (%Cong), instantaneous pendular transduction and Recovery of step, shift phase (PhaseShift).
This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
Measured: Change from baseline other Parameters of Pendular Mechanism at 8 weeks
Movement Body Center of Mass (BCoM) on X, Y, Z axis
This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
Measured: Change from baseline of BCoM at 8 weeks
Maximal voluntary contractions (MVC) of the muscles: anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG)
This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using the Miotool electromyograph
Measured: Change from baseline MVC at 8 weeks
Electromyographic Parameters (mean amplitude of the signal and co-contraction) of the muscles: anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG)
This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph
Measured: Change from baseline Electromyographic parameters at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2016

First posted31 Mar 2017
Study startMar 2014
Primary completionOct 2014
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03096964
Sponsor's protocol ID: LTartaruga,
Acronym: Pole walking
Status last verified: Mar 2017
First submitted: 8 Dec 2016
Last updated: 31 Mar 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.
PubMed 31932999
Gomenuka NA, Oliveira HB, Silva ES, Costa RR, Kanitz AC, Liedtke GV, Schuch FB, Peyre-Tartaruga LA. Effects of Nordic walking training on quality of life, balance and functional mobility in elderly: A randomized clinical trial. PLoS One. 2019 Jan 30;14(1):e0211472. doi: 10.1371/journal.pone.0211472. eCollection 2019.
PubMed 30699211

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Nordic Walking Training in Energetic, Mechanical and Neuromuscular Parameters of Elderly. A Randomized Clinical Trail
ClinicalTrials.gov ID: NCT03096964
Acronym / sponsor ID: Pole walking / LTartaruga,
Conditions: Sedentary Lifestyle, Age Problems
Keywords: Elderly training, Pole walking, Locomotor Rehabilitation Index, Self-selected speed of walking, Recovery
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Study start: Mar 2014
Primary completion: Oct 2014 (actual)
Study completion: Dec 2016 (actual)
First posted: 31 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nordic walking	Experimental	Other: Nordic walking trainingExperimental: Nordic walking Training The total period of training was composed by 8-week of walking with poles, three sessions per week. The cycles were divided into eight microcycles composed by three training sessions. Each training session took 60 min. Nordic walking aerobics training were used during the training period. These exercises were performed alternating volume and intensity. Exercise intensities were controlled using the cardiac monitor, and the zone was since 70% to 105% of the heart rate at the second ventilatory threshold. And volume was controlled using the time of the session.
Free Walking	Experimental	Other: Free walking trainingExperimental: Free walking Training The total period of training was composed by a 8-week cycles of walking without poles, with three sessions per week. The cycles were divided into eight microcycles composed by three training sessions. Each training session took 60 min. Free walking aerobics training were used during the training period. These exercises were performed alternating volume and intensity. Exercise intensities were controlled using the cardiac monitor, and the zone was since 70% to 105% of the heart rate at the second ventilatory threshold. And volume was controlled using the time of the session.

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Sedentary elderly people
Aged between 60 and 80

Key exclusion criteria (3 listed)

Smoking
Show chronic pain or presence of migraine or nausea in daily life;
History of labyrinthitis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Free walking trainingThe training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.	Other	Free Walking
Nordic walking trainingThe training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.	Other	Nordic walking

Primary outcome

Self-selected walking speed - SSWS
Time frame: Change from baseline SSWS at 8 weeks
This outcome will be measure through sub-maximal test of walking treadmill, using the portable gas analyser Equipment.

20 secondary outcomes

Quality of life (QoL)
Time frame: Change from baseline QoL at 8 weeks
Locomotor rehabilitation index (LRI)
Time frame: Change from baseline LRI at 8 weeks
Oxygen consumption (VO2)
Time frame: from baseline to 8 weeks
Cost of transport (C)
Time frame: from baseline to 8 weeks
Optimal Walking Speed (OPT)
Time frame: from baseline to 8 weeks
Oxygen Consumption at anaerobic threshold (VO2VT2)
Time frame: from baseline to 8 weeks
Peak Oxygen Consumption (VO2peak)
Time frame: from baseline to 8 weeks
Heart Rate at anaerobic threshold (HRVT2)
Time frame: from baseline to 8 weeks
Rest Heart Rate (HRrest)
Time frame: from baseline to 8 weeks
Exercise Heart Rate (HRexercise)
Time frame: from baseline to 8 weeks
Rest Arterial Systolic Blood Pressure (SBPrest)
Time frame: from baseline to 8 weeks
Rest Arterial Diastolic Blood Pressure (DBPrest)
Time frame: Change from baseline DBPrest at 8 weeks
Parameters of Static balance (Amplitude ans Speed of Center of pressure in X, Y and Z axis)
Time frame: Change from baseline Parameters of Static Balance at 8 weeks
Parameters of Dynamic variability (coefficient of variation (CoV) of Stride length (SL), stride frequency (SF), swing time (ST), and contact time (CT)
Time frame: Change from baseline Parameters of Dynamic Balance at 8 weeks
Spatial Temporal Parameters (stride frequency, stride length, swing time and contact time)
Time frame: Change from baseline Spatial Temporal parameters at 8 weeks
Parameters of Pendular Mechanism (external, internal and total mechanical work, Wext, Wint and Wtot, respectively, Recovery).
Time frame: Change from baseline Parameters of Mechanical Work at 8 weeks
Other Parameters of Pendular Mechanism (Percentage of congruity (%Cong), instantaneous pendular transduction and Recovery of step, shift phase (PhaseShift).
Time frame: Change from baseline other Parameters of Pendular Mechanism at 8 weeks
Movement Body Center of Mass (BCoM) on X, Y, Z axis
Time frame: Change from baseline of BCoM at 8 weeks
Maximal voluntary contractions (MVC) of the muscles: anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG)
Time frame: Change from baseline MVC at 8 weeks
Electromyographic Parameters (mean amplitude of the signal and co-contraction) of the muscles: anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG)
Time frame: Change from baseline Electromyographic parameters at 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
Derived from this study: PubMed 31932999Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.
Derived from this study: PubMed 30699211Gomenuka NA, Oliveira HB, Silva ES, Costa RR, Kanitz AC, Liedtke GV, Schuch FB, Peyre-Tartaruga LA. Effects of Nordic walking training on quality of life, balance and functional mobility in elderly: A randomized clinical trial. PLoS One. 2019 Jan 30;14(1):e0211472. doi: 10.1371/journal.pone.0211472. eCollection 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leonardo A Peyré-Tartaruga, PhD principal investigator

PhD student of the Federal University of Rio Grande do Sul- Brasil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Free walking training and Nordic walking training in people with Sedentary Lifestyle and Age Problems, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-selected walking speed - SSWS (time frame: Change from baseline SSWS at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096964, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.