Locomotive SyndromeNCT04546646
Elastic Band Exercises and Locomotive Syndrome
A study testing Elastic Band Exercises in people with Locomotive Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Locomotive syndrome is described as a condition in which mobility functions such as gait or Sit-to-stand are decreased due to impairment of the locomotive organs. Progression of locomotion syndrome causes limitation in carrying out activities of daily living (ADL) independently. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Locomotive Syndrome
- What is being tested?
- Elastic Band Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Aug 2020to 1 Jan 2021
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >60 years
- Both genders
- Greater than 16 score on Geriatric Locomotive Function Scale (GLFS)
- Complaints related to legs and spine without disability in walking or going out.
- Score of less than 45 in Berg Balance Scale.
- Some difficulty in walking due to locomotive organ dysfunction.
- Good communication and ability to perform activities of Short physical performance battery protocol.
Who cannot join
- Persons with severe co-morbid conditins
- Stroke
- Cardiac failure
- Cognitive impairment
- Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Elastic Band Exercises on Physical Performance in Community Dwelling Elderly With Locomotive Syndrome
Locomotive syndrome is described as a condition in which mobility functions such as gait or Sit-to-stand are decreased due to impairment of the locomotive organs. Progression of locomotion syndrome causes limitation in carrying out activities of daily living (ADL) independently. So interventions are required to limit the progression of the syndrome and to sustain the functions of locomotive organs. This study will be a randomized controlled trial in which elastic band exercises are used to enhance the physical performance of community-dwelling elderly with locomotive syndrome and changes will be recorded using different methods and tools. Non-probability convenient sampling technique will be used to collect the data. The sample size of 24 patients will be taken in this study. Patients will be randomly allocated into two different groups through sealed envelope method. Group A will be treated with elastic band exercises and Group B will have no intervention. Short physical performance battery protocol and score sheet tool will be used as outcome measure tool. Participants of both groups will be pre-tested before the application of interventional techniques and post-tested after the application of respective interventions after 3 months. Data will be analyzed on SPSS 21.
Read the detailed description
Locomotive syndrome is described as a condition in which mobility functions such as gait or Sit-to-stand are decreased due to impairment of the locomotive organs. Progression of locomotion syndrome causes limitation in carrying out activities of daily living (ADL) independently. So interventions are required to limit the progression of the syndrome and to sustain the functions of locomotive organs. Locomotive system of the body consist of 3 components which are Bones (support), joint and intervertebral discs(mobility, impact absorption) and muscular and nervous system (drive , control). Any dysfunction in these locomotive organs can lead to the development of pain, limited range of motion at joints muscle weakness and balance deficits. Common diseases of the locomotive organs which are non-traumatic etiology are chronic diseases disc degeneration, lower extremity cartilage degeneration and traumatic causes includes fractures due to osteoporosis.
Population of Japan is aging so rapidly 8-10% of people are 65 or above, and is already be seen as super aged society, it has great impact on social system including public health. Japanese did great work in this perspective and also the world .First described the term locomotive syndrome . Japanese Orthopedic Association (JOA) proposed the term of locomotive syndrome (LS) in 2007 to describe the conditions of patients with high-risk musculoskeletal diseases requiring Nursing care.GLFS-25 is geriatric locomotive function scale a screening tool developed by the JOA in 2012. A score >16 indicates the presence of locomotive syndrome. GFLS is used to Assess a participant's physical condition and lifestyle over a prior month. It is self-administered and comprehensive questionnaire having 25 items, which include questions related to pain, Activities of daily living (ADL),social function and mental health status. 25 points are Graded from 0 points(no impairment)to 4 points (severe impairment. The (SPPB )Short Physical Performance Battery Protocol And Score Sheet is commonly used To measure balance ,gait speed and lower limb strength and endurance. There is more rapid functional decline in lower extremities than in lower extremities in individuals with locomotive syndrome. SPPB score of 6 is a low performance score. Different types of intervention strategies are used for the strengthening of muscles in adults but as far as elderly individuals are concerned there is a need for the intervention which is effective, inexpensive ,easy and most importantly safe to execute. To strengthen the weakened musculature resistance exercises are commonly performed. Elastic bands are the bands or tubes of plastic material which can provide load or resistance in all directions. Elastic bands of different resistance. are available and their coloring shows strength levels. Force that an elastic band generate is directly proportional to its length. By changing the length and thickness of these bands their resistance levels can be increased or decreased. Depending on the brand of resistance band most common colors are yellow, green, red, blue, black, silver and gold with yellow being the lightest and gold the strongest. It is easy to adjust the resistance of elastic band in muscle strengthening so these are commonly used for rehabilitation treatment of disorders and sports injuries because of their low cost and simplicity. In addition to increase in physical performance elastic band exercises also decreases the depression and anxiety. It is difficult for the elderly population to adhere with a continued training so elastic band exercises can be incorporated in training which are easy and simple to perform. Almost all the exercises with elastic bands can be performed at any place while walking ,travelling and everywhere because no tool or equipment is required. Previous studies did not used elastic band exercises in community-dwelling elderly to increase the physical performance.
- Conditions
- Locomotive Syndrome
- Being tested
- Elastic Band Exercises
- Keywords
- Locomotive Syndrome, Geriatric, Elastic Band Resistance Exercises.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Band ExercisesOther
Resistance exercise will be performed using theraband. The color of the band denotes the degree of elasticity and resistance level(yellow , red ,green ,blue, black or silver).Exercise load in terms of individual yielding elasticity (band color) in resistance training will set at a level that a patient perceived as somewhat hard, which is equivalent to a 13-grade rating (moderate intensity exercise) on the RPE, According to American College of Sports Medicine. For each exercise movement 3 sets of 10 repetitions of gentle concentric and eccentric contractions through the full range of motion will be slowly performed using a yellow Thera band initially. The exercise intensity will be increased when the patient is able to achieve a perceived yield strength corresponding to a 13- grade rating on the RPE scale.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A (Elastic Band Exercises) | Experimental | Warm up: for 10 min, Exercise: Lower limb exercises using elastic band for 30 min. Cool down: Self-stretches 5 min. Receives: Other: Elastic Band Exercises |
| GROUP - B (No Intervention) | No intervention | Routine activities of daily living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery Protocol and Score Sheet
It is a clinician-rated physical measures that evaluates physical function in older adults. This assessment consist of 3 sub-scales: standing balance, gait , rising from chair . The assessment is scored on a 0-12 scale,with higher scores indicating better function. The SPPB does not require specific training ,is free to use and requires only a stopwatch and chair .
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start24 Aug 2020
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Locomotive SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546646
- Sponsor's protocol ID
- REC/Lhr/20/1044 Sania Anwaar
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akahane M, Yoshihara S, Maeyashiki A, Tanaka Y, Imamura T. Lifestyle factors are significantly associated with the locomotive syndrome: a cross-sectional study. BMC Geriatr. 2017 Oct 18;17(1):241. doi: 10.1186/s12877-017-0630-1.
PubMed 29047351Akai M, Doi T, Seichi A, Okuma Y, Ogata T, Iwaya T. Locomotive Syndrome: Operational Definition Based on a Questionnaire, and Exercise Interventions on Mobility Dysfunction in Elderly People. Clin Rev Bone Miner Metab. 2016;14:119-130. doi: 10.1007/s12018-016-9210-8. Epub 2016 Jun 3.
PubMed 27375372Iwaya T, Doi T, Seichi A, Hoshino Y, Ogata T, Akai M. Characteristics of disability in activity of daily living in elderly people associated with locomotive disorders. BMC Geriatr. 2017 Jul 26;17(1):165. doi: 10.1186/s12877-017-0543-z.
PubMed 28747158Kataoka H, Miyatake N, Ichikawa H, Arakawa Y, Mori Y. Relationship of locomotive syndrome with health-related quality of life among patients with obstructive sleep apnea syndrome. J Phys Ther Sci. 2017 Jul;29(7):1129-1133. doi: 10.1589/jpts.29.1129. Epub 2017 Jul 15.
PubMed 28744031Matsumoto H, Hagino H, Wada T, Kobayashi E. Locomotive syndrome presents a risk for falls and fractures in the elderly Japanese population. Osteoporos Sarcopenia. 2016 Sep;2(3):156-163. doi: 10.1016/j.afos.2016.06.001. Epub 2016 Jul 1.
PubMed 30775481
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Band Exercises on Physical Performance in Community Dwelling Elderly With Locomotive Syndrome
- ClinicalTrials.gov ID
- NCT04546646
- Acronym / sponsor ID
- REC/Lhr/20/1044 Sania Anwaar
- Conditions
- Locomotive Syndrome
- Keywords
- Locomotive Syndrome, Geriatric, Elastic Band Resistance Exercises.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 14 Sep 2020 (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.
Locomotive syndrome is described as a condition in which mobility functions such as gait or Sit-to-stand are decreased due to impairment of the locomotive organs. Progression of locomotion syndrome causes limitation in carrying out activities of daily living (ADL) independently. So interventions are required to limit the progression of the syndrome and to sustain the functions of locomotive organs. This study will be a randomized controlled trial in which elastic band exercises are used to enhance the physical performance of community-dwelling elderly with locomotive syndrome and changes will be recorded using different methods and tools. Non-probability convenient sampling technique will be used to collect the data. The sample size of 24 patients will be taken in this study. Patients will be randomly allocated into two different groups through sealed envelope method. Group A will be treated with elastic band exercises and Group B will have no intervention. Short physical performance battery protocol and score sheet tool will be used as outcome measure tool. Participants of both groups will be pre-tested before the application of interventional techniques and post-tested after the application of respective interventions after 3 months. Data will be analyzed on SPSS 21.
Detailed description
Locomotive syndrome is described as a condition in which mobility functions such as gait or Sit-to-stand are decreased due to impairment of the locomotive organs. Progression of locomotion syndrome causes limitation in carrying out activities of daily living (ADL) independently. So interventions are required to limit the progression of the syndrome and to sustain the functions of locomotive organs. Locomotive system of the body consist of 3 components which are Bones (support), joint and intervertebral discs(mobility, impact absorption) and muscular and nervous system (drive , control). Any dysfunction in these locomotive organs can lead to the development of pain, limited range of motion at joints muscle weakness and balance deficits. Common diseases of the locomotive organs which are non-traumatic etiology are chronic diseases disc degeneration, lower extremity cartilage degeneration and traumatic causes includes fractures due to osteoporosis.
Population of Japan is aging so rapidly 8-10% of people are 65 or above, and is already be seen as super aged society, it has great impact on social system including public health. Japanese did great work in this perspective and also the world .First described the term locomotive syndrome . Japanese Orthopedic Association (JOA) proposed the term of locomotive syndrome (LS) in 2007 to describe the conditions of patients with high-risk musculoskeletal diseases requiring Nursing care.GLFS-25 is geriatric locomotive function scale a screening tool developed by the JOA in 2012. A score >16 indicates the presence of locomotive syndrome. GFLS is used to Assess a participant's physical condition and lifestyle over a prior month. It is self-administered and comprehensive questionnaire having 25 items, which include questions related to pain, Activities of daily living (ADL),social function and mental health status. 25 points are Graded from 0 points(no impairment)to 4 points (severe impairment. The (SPPB )Short Physical Performance Battery Protocol And Score Sheet is commonly used To measure balance ,gait speed and lower limb strength and endurance. There is more rapid functional decline in lower extremities than in lower extremities in individuals with locomotive syndrome. SPPB score of 6 is a low performance score. Different types of intervention strategies are used for the strengthening of muscles in adults but as far as elderly individuals are concerned there is a need for the intervention which is effective, inexpensive ,easy and most importantly safe to execute. To strengthen the weakened musculature resistance exercises are commonly performed. Elastic bands are the bands or tubes of plastic material which can provide load or resistance in all directions. Elastic bands of different resistance. are available and their coloring shows strength levels. Force that an elastic band generate is directly proportional to its length. By changing the length and thickness of these bands their resistance levels can be increased or decreased. Depending on the brand of resistance band most common colors are yellow, green, red, blue, black, silver and gold with yellow being the lightest and gold the strongest. It is easy to adjust the resistance of elastic band in muscle strengthening so these are commonly used for rehabilitation treatment of disorders and sports injuries because of their low cost and simplicity. In addition to increase in physical performance elastic band exercises also decreases the depression and anxiety. It is difficult for the elderly population to adhere with a continued training so elastic band exercises can be incorporated in training which are easy and simple to perform. Almost all the exercises with elastic bands can be performed at any place while walking ,travelling and everywhere because no tool or equipment is required. Previous studies did not used elastic band exercises in community-dwelling elderly to increase the physical performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| GROUP A (Elastic Band Exercises) | Experimental | Other: Elastic Band ExercisesWarm up: for 10 min, Exercise: Lower limb exercises using elastic band for 30 min. Cool down: Self-stretches 5 min. |
| GROUP - B (No Intervention) | No intervention | –Routine activities of daily living |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >60 years
- Both genders
- Greater than 16 score on Geriatric Locomotive Function Scale (GLFS)
- Complaints related to legs and spine without disability in walking or going out.
- Score of less than 45 in Berg Balance Scale.
Key exclusion criteria (5 listed)
- Persons with severe co-morbid conditins
- Stroke
- Cardiac failure
- Cognitive impairment
- Alzheimer's disease
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 |
|---|---|---|
| Elastic Band ExercisesResistance exercise will be performed using theraband. The color of the band denotes the degree of elasticity and resistance level(yellow , red ,green ,blue, black or silver).Exercise load in terms of individual yielding elasticity (band color) in resistance training will set at a level that a patient perceived as somewhat hard, which is equivalent to a 13-grade rating (moderate intensity exercise) on the RPE, According to American College of Sports Medicine. For each exercise movement 3 sets of 10 repetitions of gentle concentric and eccentric contractions through the full range of motion will be slowly performed using a yellow Thera band initially. The exercise intensity will be increased when the patient is able to achieve a perceived yield strength corresponding to a 13- grade rating on the RPE scale. | Other | GROUP A (Elastic Band Exercises) |
Primary outcome
Short Physical Performance Battery Protocol and Score Sheet
Time frame: 12 Weeks
It is a clinician-rated physical measures that evaluates physical function in older adults. This assessment consist of 3 sub-scales: standing balance, gait , rising from chair . The assessment is scored on a 0-12 scale,with higher scores indicating better function. The SPPB does not require specific training ,is free to use and requires only a stopwatch and chair .
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 1 Apr 2021.
- Background: PubMed 29047351Akahane M, Yoshihara S, Maeyashiki A, Tanaka Y, Imamura T. Lifestyle factors are significantly associated with the locomotive syndrome: a cross-sectional study. BMC Geriatr. 2017 Oct 18;17(1):241. doi: 10.1186/s12877-017-0630-1.
- Background: PubMed 27375372Akai M, Doi T, Seichi A, Okuma Y, Ogata T, Iwaya T. Locomotive Syndrome: Operational Definition Based on a Questionnaire, and Exercise Interventions on Mobility Dysfunction in Elderly People. Clin Rev Bone Miner Metab. 2016;14:119-130. doi: 10.1007/s12018-016-9210-8. Epub 2016 Jun 3.
- Background: PubMed 28747158Iwaya T, Doi T, Seichi A, Hoshino Y, Ogata T, Akai M. Characteristics of disability in activity of daily living in elderly people associated with locomotive disorders. BMC Geriatr. 2017 Jul 26;17(1):165. doi: 10.1186/s12877-017-0543-z.
- Background: PubMed 28744031Kataoka H, Miyatake N, Ichikawa H, Arakawa Y, Mori Y. Relationship of locomotive syndrome with health-related quality of life among patients with obstructive sleep apnea syndrome. J Phys Ther Sci. 2017 Jul;29(7):1129-1133. doi: 10.1589/jpts.29.1129. Epub 2017 Jul 15.
- Background: PubMed 30775481Matsumoto H, Hagino H, Wada T, Kobayashi E. Locomotive syndrome presents a risk for falls and fractures in the elderly Japanese population. Osteoporos Sarcopenia. 2016 Sep;2(3):156-163. doi: 10.1016/j.afos.2016.06.001. Epub 2016 Jul 1.
- Individual participant dataSharing planned: No
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.
Danish Hassan, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band Exercises in people with Locomotive Syndrome, run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 5 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 1 Apr 2021. 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 Pakistan. 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?
Short Physical Performance Battery Protocol and Score Sheet (time frame: 12 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 NCT04546646, which also lists 5 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 1 Apr 2021.