Older AdultsNCT05130372
Comparison of The Acute Effects of Different Stretching Methods on Ankle Joint Range In Healty Older Adults
A study testing Static Stretching Method Group, PNF Stretching Method Group and Myofascial Relaxation Method Group- Roller Massage in people with Older Adults and Range of Motion, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
Introduction: To compare the acute effects of different stretching methods on ankle joint range of motion (ROM) in older adults. Methods: A total of 78 subjects aged 65 years and older were randomly divided into three groups. After the 5-minute walk, the randomly assigned method was applied. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Range of Motion, Ankle Injuries
- What is being tested?
- Static Stretching Method Group, PNF Stretching Method Group and Myofascial Relaxation Method Group- Roller Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 27 Feb 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy and voluntary older adults aged 65 and over
- Who were able to walk without using an assistive device,
- Independent in their daily life activities
- Who scored 23 and above according to the mini-mental state test.
Who cannot join
- Presence of a neurological, orthopedic or cardiovascular disease affecting the lower extremity,
- Pain or limitation of movement in the ankle joint,
- Skin diseases,
- History of falling in the last 1 year,
- Any problem that may prevent lying prone
- participation in a regular exercise program.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Izmir Provincial Health Directorate State Hospital
Izmir, Urla
Izmir Provincial Health Directorate Urla State Hospital
Izmir, Urla
About this study
Official title: Comparison of The Acute Effects of Different Stretching Techniques on Ankle Joint Range of Motion In Healthy Older Adults: A Randomised Controlled Trial
Introduction: To compare the acute effects of different stretching methods on ankle joint range of motion (ROM) in older adults.
Methods: A total of 78 subjects aged 65 years and older were randomly divided into three groups. After the 5-minute walk, the randomly assigned method was applied. Static Stretching Group; static stretching in 3x30sec, PNF Stretching Group; PNF contract-relax in 3x30sec and Roller Massage Group; roller massage in 3x30sec was performed. Immediately after the application, 10 minutes and 20 minutes after application, the range of motion of the ankle joint was measured in the weight-bearing lunge position.
Read the detailed description
It is planned to single-blind, randomized controlled study with before-after measurements. Considering the acute effects of stretching exercise for ankle dorsiflexion in older women, the effect size was calculated as 1.02. According to this effect size, it was planned to recruit 26 people to each group with 95% confidence level and 95% power, and 78 people in total would participate in the study. Ethics committee approval of the study was received from Dokuz Eylul University Non-Interventional Research Ethics Committee (with the decision number 2017/17-39 in the meeting dated 22.06.2017). The study was conducted under the Declaration of Helsinki standards. The participants were informed about the study by the physiotherapist and all the participants provided written informed consent to participate in the study. The study included healthy and voluntary older adults aged 65 and over who were able to walk without using an assistive device, independent in their daily life activities, and scored 23 and above according to the mini-mental state test in the study. The exclusion criteria of the study were the presence of a neurological, orthopedic or cardiovascular disease affecting the lower extremity, pain or limitation of movement in the ankle joint, skin diseases, history of falling in the last 1 year, any problem that may prevent lying prone and participation in a regular exercise program. Individuals meeting the inclusion criteria were randomly assigned to one of two different groups with the help of the Random Numbers Table. The study was terminated when the target number of participants (n=78) was reached. Static stretching was applied to the first group (n=26), PNF stretching to the second group (n=26), and roller massage to the third group (n=26). Individuals meeting the inclusion criteria were randomly assigned to one of two different groups with the help of the Random Numbers Table. The study was terminated when the target number of participants (n=78) was reached. Static stretching was applied to the first group (n=26), PNF stretching to the second group (n=26), and roller massage to the third group (n=26). (Figure 1) After the stretching method to be applied was determined randomly, the participants were asked to walk for 5 minutes in a 50-meter corridor. After warming up with this light-paced walking, applied one of the three methods. Immediately after the application, 10 minutes and 20 minutes after application, the range of motion of the ankle joint was measured in the weight-bearing lunge position.
- Conditions
- Older Adults, Range of Motion, Ankle Injuries
- Being tested
- Static Stretching Method Group, PNF Stretching Method Group, Myofascial Relaxation Method Group- Roller Massage
- Keywords
- older adults, ankle joint range of motion, roller massage, static stretching, PNF stretching
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Stretching Method GroupOther
Static stretching has been the most common stretching method applied to the ankle in healthy older adults, and different protocols have proven to increase ankle range of motion. In this study, the static stretching method was actively applied while standing.
PNF Stretching Method GroupOther
The contract-relax technique was used in the PNF stretching method.
Myofascial Relaxation Method Group- Roller MassageOther
A theraband roller massager (Theraband®, The Hygenic Corporation, Akron, OH) was used for the myofascial relaxation method.
| Study group | Role | What they receive |
|---|---|---|
| Static Stretching Group | Active comparator | The static stretching method was actively applied while standing.The person was positioned facing the wall, supporting the wall with both hands, with the dominant foot behind. The point where a feeling of tension in the plantar flexor muscles was created and held in this position for 30 seconds. Afterward, a 15-second rest break was given. After completing 3 repetitions (3x30sec) in total, measurements were started. Receives: Other: Static Stretching Method Group |
| PNF Stretching Method Group | Active comparator | The person was positioned supine, and the ankle joint was dorsiflexed by the physiotherapist to the point where the tension was felt. Then, while the person was trying to push the foot towards the plantarflexion direction for 10 seconds, the movement was prevented by the physiotherapist and isometric contraction was achieved at 20% of the maximum voluntary contraction. After 10 seconds, the person was asked to relax slowly and passive stretching was applied to the plantar flexors for 20 seconds. The contract-relax technique was applied for 30 seconds and completed with 3 repetitions (3x30sec) with 15-second rest intervals. Receives: Other: PNF Stretching Method Group |
| Myofascial Relaxation Method Group | Active comparator | A comfortable position was achieved by placing a rolled towel on the front of the ankle. The roller was massaged along with the plantar flexors for 30 seconds. The movement of the cylinder from bottom to top and from top to bottom was done for a second. Three repetitions were completed (3x30sec) with a 15-second rest break. For the pressure of the roller to be stable during the application, the numbered pain scale was shown to the participants, and attention was paid to ensure that the perceived severity was 7/10 according to the numbered pain scale. Participants with dry skin in the application area were asked to moisturize with cream beforehand to avoid complications. Receives: Other: Myofascial Relaxation Method Group- Roller Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Measured: Baseline
Range of motion
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Measured: Immediately after application
Range of motion
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Measured: 10 minutes after application
Range of motion
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Measured: 20 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Oct 2017
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Model description
- Arm 1:Static Stretching Group Arm 2: PNF Stretching Method Group Arm 3:Roller Massager Group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Nursen İlçin, Ceren Devrim Şahin
- Responsible party
- Principal investigator, Kutay Kaslı, Hacettepe University
- Investigators
- Ceren Devrim Şahin, MSc, Study director, Dokuz Eylul UniversityNursen İlçin, Assoc. prof., Study chair, Dokuz Eylul UniversityKutay Kaşlı, MSc, Principal investigator, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130372
- Sponsor's protocol ID
- 2017/17-39
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be shared if it is in line with the objectives of the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Acute Effects of Different Stretching Techniques on Ankle Joint Range of Motion In Healthy Older Adults: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05130372
- Acronym / sponsor ID
- 2017/17-39
- Conditions
- Older Adults, Range of Motion, Ankle Injuries
- Keywords
- older adults, ankle joint range of motion, roller massage, static stretching, PNF stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Nursen İlçin, Ceren Devrim Şahin
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 23 Nov 2021 (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.
Introduction: To compare the acute effects of different stretching methods on ankle joint range of motion (ROM) in older adults.
Methods: A total of 78 subjects aged 65 years and older were randomly divided into three groups. After the 5-minute walk, the randomly assigned method was applied. Static Stretching Group; static stretching in 3x30sec, PNF Stretching Group; PNF contract-relax in 3x30sec and Roller Massage Group; roller massage in 3x30sec was performed. Immediately after the application, 10 minutes and 20 minutes after application, the range of motion of the ankle joint was measured in the weight-bearing lunge position.
Detailed description
It is planned to single-blind, randomized controlled study with before-after measurements. Considering the acute effects of stretching exercise for ankle dorsiflexion in older women, the effect size was calculated as 1.02. According to this effect size, it was planned to recruit 26 people to each group with 95% confidence level and 95% power, and 78 people in total would participate in the study. Ethics committee approval of the study was received from Dokuz Eylul University Non-Interventional Research Ethics Committee (with the decision number 2017/17-39 in the meeting dated 22.06.2017). The study was conducted under the Declaration of Helsinki standards. The participants were informed about the study by the physiotherapist and all the participants provided written informed consent to participate in the study. The study included healthy and voluntary older adults aged 65 and over who were able to walk without using an assistive device, independent in their daily life activities, and scored 23 and above according to the mini-mental state test in the study. The exclusion criteria of the study were the presence of a neurological, orthopedic or cardiovascular disease affecting the lower extremity, pain or limitation of movement in the ankle joint, skin diseases, history of falling in the last 1 year, any problem that may prevent lying prone and participation in a regular exercise program. Individuals meeting the inclusion criteria were randomly assigned to one of two different groups with the help of the Random Numbers Table. The study was terminated when the target number of participants (n=78) was reached. Static stretching was applied to the first group (n=26), PNF stretching to the second group (n=26), and roller massage to the third group (n=26). Individuals meeting the inclusion criteria were randomly assigned to one of two different groups with the help of the Random Numbers Table. The study was terminated when the target number of participants (n=78) was reached. Static stretching was applied to the first group (n=26), PNF stretching to the second group (n=26), and roller massage to the third group (n=26). (Figure 1) After the stretching method to be applied was determined randomly, the participants were asked to walk for 5 minutes in a 50-meter corridor. After warming up with this light-paced walking, applied one of the three methods. Immediately after the application, 10 minutes and 20 minutes after application, the range of motion of the ankle joint was measured in the weight-bearing lunge position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Arm 1:Static Stretching Group Arm 2: PNF Stretching Method Group Arm 3:Roller Massager Group
| Arm | Type | Receives |
|---|---|---|
| Static Stretching Group | Active comparator | Other: Static Stretching Method GroupThe static stretching method was actively applied while standing.The person was positioned facing the wall, supporting the wall with both hands, with the dominant foot behind. The point where a feeling of tension in the plantar flexor muscles was created and held in this position for 30 seconds. Afterward, a 15-second rest break was given. After completing 3 repetitions (3x30sec) in total, measurements were started. |
| PNF Stretching Method Group | Active comparator | Other: PNF Stretching Method GroupThe person was positioned supine, and the ankle joint was dorsiflexed by the physiotherapist to the point where the tension was felt. Then, while the person was trying to push the foot towards the plantarflexion direction for 10 seconds, the movement was prevented by the physiotherapist and isometric contraction was achieved at 20% of the maximum voluntary contraction. After 10 seconds, the person was asked to relax slowly and passive stretching was applied to the plantar flexors for 20 seconds. The contract-relax technique was applied for 30 seconds and completed with 3 repetitions (3x30sec) with 15-second rest intervals. |
| Myofascial Relaxation Method Group | Active comparator | Other: Myofascial Relaxation Method Group- Roller MassageA comfortable position was achieved by placing a rolled towel on the front of the ankle. The roller was massaged along with the plantar flexors for 30 seconds. The movement of the cylinder from bottom to top and from top to bottom was done for a second. Three repetitions were completed (3x30sec) with a 15-second rest break. For the pressure of the roller to be stable during the application, the numbered pain scale was shown to the participants, and attention was paid to ensure that the perceived severity was 7/10 according to the numbered pain scale. Participants with dry skin in the application area were asked to moisturize with cream beforehand to avoid complications. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Healthy and voluntary older adults aged 65 and over
- Who were able to walk without using an assistive device,
- Independent in their daily life activities
- Who scored 23 and above according to the mini-mental state test.
Key exclusion criteria (6 listed)
- Presence of a neurological, orthopedic or cardiovascular disease affecting the lower extremity,
- Pain or limitation of movement in the ankle joint,
- Skin diseases,
- History of falling in the last 1 year,
- Any problem that may prevent lying prone
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 |
|---|---|---|
| Static Stretching Method GroupStatic stretching has been the most common stretching method applied to the ankle in healthy older adults, and different protocols have proven to increase ankle range of motion. In this study, the static stretching method was actively applied while standing. | Other | Static Stretching Group |
| PNF Stretching Method GroupThe contract-relax technique was used in the PNF stretching method. | Other | PNF Stretching Method Group |
| Myofascial Relaxation Method Group- Roller MassageA theraband roller massager (Theraband®, The Hygenic Corporation, Akron, OH) was used for the myofascial relaxation method. | Other | Myofascial Relaxation Method Group |
Primary outcome
Range of motion
Time frame: Baseline
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Range of motion
Time frame: Immediately after application
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Range of motion
Time frame: 10 minutes after application
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
Range of motion
Time frame: 20 minutes after application
The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position.
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 23 Nov 2021.
- Individual participant dataSharing planned: Undecided. It will be shared if it is in line with the objectives of the study.
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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.
Ceren Devrim Şahin, MSc study director
Dokuz Eylul University
Nursen İlçin, Assoc. prof. study chair
Dokuz Eylul University
Kutay Kaşlı, MSc principal investigator
Çankırı Karatekin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Stretching Method Group, PNF Stretching Method Group and Myofascial Relaxation Method Group- Roller Massage in people with Older Adults and Range of Motion, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 6 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Range of motion (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2021.