Resistance TrainingNCT05023642
Training-induced Muscle Strength and Its Role in Interface Pressure in Inelastic Compression
A study testing resistance training in people with Resistance Training, run by Pró Circulação® at 2 sites in Brazil.
Trial summary
The present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression? Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resistance Training
- What is being tested?
- resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesBrazil
- Study dates
- 3 May 2021to 18 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs.
Who cannot join
- Participants who present chronic venous insufficiency (CEAP C3-6) evaluated through Doppler ultrasonography, severe congestive heart failure (functional class III and IV - NYHA), and Ankle/Brachial Index (ABI) < 0.8. We will also exclude elderly individuals who are unable to perform the required exercises due to physical limitations and those bedridden or wheelchair-bound.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Unochapecó University
Chapecó, Santa Catarina, 89.809-900
Pró Circulação® - Clinic of Angiology and Vascular Surgery
Xanxerê, Santa Catarina, 89.820-000
About this study
Official title: Training-induced Muscle Strength Increase and Its Role in Interface Pressure in Inelastic Compression: A Randomized Clinical Trial
The present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression?
Read the detailed description
This phase I two-armed randomized clinical trial including participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in resistance exercise programs will be conducted at the Ativas Gym, Xanxere/SC, Brazil. Participants will perform exercises during the strength-training protocol intervention, while individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. In addition, we will monitor their eating and physical activity habits throughout the data collection period. The study was designed in accordance with the CONSORT statement.
- Conditions
- Resistance Training
- Being tested
- resistance training
- Keywords
- Inelastic compression, Resistance exercise, Muscle hypertrophy, Chronic venous disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingOther
Interventions will include a three-phase strengthening training protocol.
- Adaptation phase: three sessions, emphasis on learning the technique, body self-awareness, and movement coordination;
- Basic phase: 12 sessions, to increase muscle strength; and
- Specific phase: 21 sessions, to intensify the process of strength gain and muscular hypertrophy.
Participants will perform the following exercises during the strength-training protocol intervention: pec deck/seated lever fly, adductor, pulldown, abductor strengthening, alternating dumbbell curl, leg press at a 45-angle, triceps pulley, lateral raise, knee flexion and extension, ankle joint flexion and extension in the leg press, and crunches. If the participant has difficulty performing a specific exercise, an equivalent activity will replace it. From the eighth week onwards, participants will perform additional exercises focused on strengthening the gastrocnemius and soleus.
| Study group | Role | What they receive |
|---|---|---|
| resistance training | Experimental | Participants will not be offered the exercise program in the three months before data collection.
From then on, participants will perform exercises during the resistance training protocol intervention. Receives: Other: resistance training |
| control group | No intervention | Individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body composition at 12 weeks
The body composition assessment will be performed through Dual-Energy X-Ray Absorptiometry (DXA) examination, on the first and last day of the study, in both groups, with the participant fasting, without having exercised in the last 24 hours (Andreoli et., 2009).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline muscle strength at 12 weeks
Muscle strength assessments will be performed at the beginning and end of the intervention (pre-test and post-test) in all study participants. After warming up the lower limbs, based on dynamic movements, for three minutes, each participant will perform between six and eight repetitions with 50% of the estimated maximum load and, one minute later, three repetitions with 70% of the estimated load. Three minutes after the specific warm-up, the test will start. An interval of two minutes will be considered between each attempt, and no more than five attempts will be made for each participant. The load corresponding to the last successful attempt will be considered as a result (Brown \& Weir, 2001).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline handgrip strength at 12 weeks
We will perform the handgrip test assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants. We will use a dynamometer in the sitting position, with the shoulder slightly adducted, elbow flexed to 90º, forearm in a neutral position, and, finally, the position of the wrist can vary from 0 to 30º of extension. Three 3-second isometric muscle contractions will be performed, in order to record the handgrip strength obtained (Fernandes \& Marins, 2011).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline walking speed at 12 weeks
We will perform walking speed assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants. Will be evaluated through the test of walking speed of 4 meters, participants will perform the test walking with normal stride speed throughout the course (Braden, 2012).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline interface pressure at 12 weeks
We will measure the interface pressure exerted by the bandage/velcro device at point B1 (the area located at the transition between the Achilles tendon and the muscular portion of the medial gastrocnemius muscle). We will perform the interface pressure assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants using a PicoPress pneumatic system.
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline Static Stiffness Index at 12 weeks
Static Stiffness Index will be calculated by the difference in the interface pressure measure between the supine and standing positions, at the beginning and end of the intervention (pre-test and post-test).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline Working Pressure Amplitude at 12 weeks
Working Pressure Amplitude (WPA) will be considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements of the ankle joint and during walking. And will be performed at the beginning and end of the intervention (pre-test and post-test).
Measured: Baseline visit and follow-up after 12 weeks
Secondary outcomes (3)
Change from quality of life assessment at 12 weeks
The Short-Form 36 (SF-36) questionnaire will be used; scores will be assigned to each question. Changing the scale from zero to 100, values closer to zero being considered a negative perception of quality of life and close to 100 as a positive perception of quality of life (Ciconelli et al., 1999).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline lower limbs' functional strength at 12 weeks
We will evaluate lower limbs' functional strength at the beginning and end of the intervention (pre-test and post-test) in all study participants. Using the Chair-test, it will be measured using a chair without armrests with a seat height of approximately 43 cm from the floor. The test will start with the participant sitting in the middle of the chair. At the signal, the participant will rise to full extension of the knee joint (upright body) and then return to the starting sitting position (Jones et al., 1999).
Measured: Baseline visit and follow-up after 12 weeks
Change from baseline dynamic balance at 12 weeks
It will be performed using the timed up and go test. The test consists of getting up from a chair, going around a cone three meters away, and sitting back down on the chair. The time it takes the subject to get up from a chair, walk, return to the chair and sit down again is recorded (Podsiadlo \& Richardson, 1991).
Measured: Baseline visit and follow-up after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start3 May 2021
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Resistance TrainingStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pró Circulação®
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Matta, MD, Principal investigator, Pró Circulação®Clodoaldo A. De Sá, Ph.D., Principal investigator, Unochapecó
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023642
- Sponsor's protocol ID
- Strengthinelastic
- Status last verified
- Jul 2022
- First submitted
- 9 Aug 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreoli A, Scalzo G, Masala S, Tarantino U, Guglielmi G. Body composition assessment by dual-energy X-ray absorptiometry (DXA). Radiol Med. 2009 Mar;114(2):286-300. doi: 10.1007/s11547-009-0369-7. Epub 2009 Mar 5. English, Italian.
PubMed 19266259Brown LE, Weir JP. Asep procedures recommendation I: accurate assessment of muscular strength and power. Journal of Exercise Physiology Online. 2001;4:1-21.
Fernandes, A.A., Marins, J.C.B.. Teste de força de preensão manual: analise metodológica e dados normativos em atletas. Fisoter Mov. 2011;24(3):567-78.
Braden, H. Self-selected gait speed: A critical clinical outcome. Lower Extremity Review. 2012 Nov.
Ciconelli, RM, et al. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Ver Bras Reumatol. 1999;39(3):143-150.
Yim E, Richmond NA, Baquerizo K, Van Driessche F, Slade HB, Pieper B, Kirsner RS. The effect of ankle range of motion on venous ulcer healing rates. Wound Repair Regen. 2014 Jul-Aug;22(4):492-6. doi: 10.1111/wrr.12186.
PubMed 25041619Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Rubin RW, Maher M. Actin turnover during encystation in Acanthamoeba. Exp Cell Res. 1976 Nov;103(1):159-68. doi: 10.1016/0014-4827(76)90251-2. No abstract available.
PubMed 991946Da Matta, E.S. et al. A Combined Therapy Protocol to Improve Lower Extremity Muscle Pumping Function and Lymphatic Drainage for Venous Ulcer Healing. J Vasc Med Surg. 2017;5:347. Doi: 10.4172/2329-6925.1000347
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training-induced Muscle Strength Increase and Its Role in Interface Pressure in Inelastic Compression: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05023642
- Acronym / sponsor ID
- Strengthinelastic
- Conditions
- Resistance Training
- Keywords
- Inelastic compression, Resistance exercise, Muscle hypertrophy, Chronic venous disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Pró Circulação®University, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 26 Aug 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.
The present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression?
Detailed description
This phase I two-armed randomized clinical trial including participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in resistance exercise programs will be conducted at the Ativas Gym, Xanxere/SC, Brazil. Participants will perform exercises during the strength-training protocol intervention, while individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. In addition, we will monitor their eating and physical activity habits throughout the data collection period. The study was designed in accordance with the CONSORT statement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance training | Experimental | Other: resistance trainingParticipants will not be offered the exercise program in the three months before data collection. From then on, participants will perform exercises during the resistance training protocol intervention. |
| control group | No intervention | –Individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs.
Key exclusion criteria (1 listed)
- Participants who present chronic venous insufficiency (CEAP C3-6) evaluated through Doppler ultrasonography, severe congestive heart failure (functional class III and IV - NYHA), and Ankle/Brachial Index (ABI) < 0.8. We will also exclude elderly individuals who are unable to perform the required exercises due to physical limitations and those bedridden or wheelchair-bound.
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 |
|---|---|---|
| resistance trainingInterventions will include a three-phase strengthening training protocol. 1. Adaptation phase: three sessions, emphasis on learning the technique, body self-awareness, and movement coordination; 2. Basic phase: 12 sessions, to increase muscle strength; and 3. Specific phase: 21 sessions, to intensify the process of strength gain and muscular hypertrophy. Participants will perform the following exercises during the strength-training protocol intervention: pec deck/seated lever fly, adductor, pulldown, abductor strengthening, alternating dumbbell curl, leg press at a 45-angle, triceps pulley, lateral raise, knee flexion and extension, ankle joint flexion and extension in the leg press, and crunches. If the participant has difficulty performing a specific exercise, an equivalent activity will replace it. From the eighth week onwards, participants will perform additional exercises focused on strengthening the gastrocnemius and soleus. | Other | resistance training |
Primary outcome
Change from baseline body composition at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
The body composition assessment will be performed through Dual-Energy X-Ray Absorptiometry (DXA) examination, on the first and last day of the study, in both groups, with the participant fasting, without having exercised in the last 24 hours (Andreoli et., 2009).
Change from baseline muscle strength at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
Muscle strength assessments will be performed at the beginning and end of the intervention (pre-test and post-test) in all study participants. After warming up the lower limbs, based on dynamic movements, for three minutes, each participant will perform between six and eight repetitions with 50% of the estimated maximum load and, one minute later, three repetitions with 70% of the estimated load. Three minutes after the specific warm-up, the test will start. An interval of two minutes will be considered between each attempt, and no more than five attempts will be made for each participant. The load corresponding to the last successful attempt will be considered as a result (Brown \& Weir, 2001).
Change from baseline handgrip strength at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
We will perform the handgrip test assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants. We will use a dynamometer in the sitting position, with the shoulder slightly adducted, elbow flexed to 90º, forearm in a neutral position, and, finally, the position of the wrist can vary from 0 to 30º of extension. Three 3-second isometric muscle contractions will be performed, in order to record the handgrip strength obtained (Fernandes \& Marins, 2011).
Change from baseline walking speed at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
We will perform walking speed assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants. Will be evaluated through the test of walking speed of 4 meters, participants will perform the test walking with normal stride speed throughout the course (Braden, 2012).
Change from baseline interface pressure at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
We will measure the interface pressure exerted by the bandage/velcro device at point B1 (the area located at the transition between the Achilles tendon and the muscular portion of the medial gastrocnemius muscle). We will perform the interface pressure assessments at the beginning and end of the intervention (pre-test and post-test) in all study participants using a PicoPress pneumatic system.
Change from baseline Static Stiffness Index at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
Static Stiffness Index will be calculated by the difference in the interface pressure measure between the supine and standing positions, at the beginning and end of the intervention (pre-test and post-test).
Change from baseline Working Pressure Amplitude at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
Working Pressure Amplitude (WPA) will be considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements of the ankle joint and during walking. And will be performed at the beginning and end of the intervention (pre-test and post-test).
3 secondary outcomes
Change from quality of life assessment at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
Change from baseline lower limbs' functional strength at 12 weeks
Time frame: Baseline visit and follow-up after 12 weeks
Change from baseline dynamic balance at 12 weeks
Time frame: Baseline visit and follow-up after 12 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 21 Jul 2022.
- Background: PubMed 19266259Andreoli A, Scalzo G, Masala S, Tarantino U, Guglielmi G. Body composition assessment by dual-energy X-ray absorptiometry (DXA). Radiol Med. 2009 Mar;114(2):286-300. doi: 10.1007/s11547-009-0369-7. Epub 2009 Mar 5. English, Italian.
- BackgroundBrown LE, Weir JP. Asep procedures recommendation I: accurate assessment of muscular strength and power. Journal of Exercise Physiology Online. 2001;4:1-21.
- BackgroundFernandes, A.A., Marins, J.C.B.. Teste de força de preensão manual: analise metodológica e dados normativos em atletas. Fisoter Mov. 2011;24(3):567-78.
- BackgroundBraden, H. Self-selected gait speed: A critical clinical outcome. Lower Extremity Review. 2012 Nov.
- BackgroundCiconelli, RM, et al. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Ver Bras Reumatol. 1999;39(3):143-150.
- Background: PubMed 25041619Yim E, Richmond NA, Baquerizo K, Van Driessche F, Slade HB, Pieper B, Kirsner RS. The effect of ankle range of motion on venous ulcer healing rates. Wound Repair Regen. 2014 Jul-Aug;22(4):492-6. doi: 10.1111/wrr.12186.
- Background: PubMed 10380242Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
- Background: PubMed 991946Rubin RW, Maher M. Actin turnover during encystation in Acanthamoeba. Exp Cell Res. 1976 Nov;103(1):159-68. doi: 10.1016/0014-4827(76)90251-2. No abstract available.
- BackgroundDa Matta, E.S. et al. A Combined Therapy Protocol to Improve Lower Extremity Muscle Pumping Function and Lymphatic Drainage for Venous Ulcer Healing. J Vasc Med Surg. 2017;5:347. Doi: 10.4172/2329-6925.1000347
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- 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.
Eduardo Matta, MD principal investigator
Pró Circulação®
Clodoaldo A. De Sá, Ph.D. principal investigator
Unochapecó
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training in people with Resistance Training, run by Pró Circulação® at 2 sites 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 1 inclusion and 1 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 21 Jul 2022. 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 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?
Change from baseline body composition at 12 weeks (time frame: Baseline visit and follow-up after 12 weeks). The study lists 7 primary outcomes in all. 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 NCT05023642, which also lists 10 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 21 Jul 2022.