Older PeopleNCT05144815
Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People
A study testing IPC + Exercise protocol in people with Older People, run by University of Valencia at 2 sites in Spain.
Trial summary
In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Older People
- What is being tested?
- IPC + Exercise protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesSpain
- Study dates
- 12 Nov 2021to 30 Dec 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age between 65 -90 years
- Physically inactive (< 150 minutes of physical activity per week).
- Signed informed consent form
Who cannot join
- Institutionalised patients.
- History of stroke in the last 6 months or hospital admission for any reason in the last 3 months.
- Uncontrolled hypertension.
- Medication with anticoagulants.
- Oncological patient with active treatment: chemotherapy or radiotherapy.
- Neurological or cardiovascular musculoskeletal pathology that contraindicates physical activity.
- Cognitive impairment (score below 25 on the "Mini-mental Test"); or severe disability (score below 15 points on the Barthel scale).
- Completion of less than 80% of training sessions.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Elena Muñoz
Valencia, Valencia / València, 46022
Marta Inglés
Valencia, 46002
About this study
Official title: Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People: a Randomised Clinical Trial
In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018).
In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, \& Harridge, 2019).
Read more
A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, \& Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, \& Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking.
Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.
Read the detailed description
In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018).
In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, \& Harridge, 2019).
Resistance or endurance training can improve sarcopenia, reduce intramuscular fat accumulation, improve muscle function, among others. Aerobic exercise has been shown to be effective in maintaining muscle mass and strength in older adults is walking (Kubo et al., 2008). In fact, walking can also improve VO2max in older adults when intensities are above ∼40% VO2max (Nemoto, Gen-no, Masuki, Okazaki, \& Nose, 2007). In addition, it has been linked to the prevention of cognitive decline (Maki et al., 2012) and improvements in quality of life (Awick et al., 2015) in older people.
A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, \& Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, \& Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking.
Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.
Therefore, this study is a randomized clinical trial in which three groups of twenty people in each group will participate, with different interventions:
- Experimental group 1: Exercise protocol + IPC.
- Experimental group 2: Exercise protocol + sham IPC.
- Control group. Participants will be evaluated in four moments, at baseline, immediately after the first session, postintervention (after 6-week intervention) and 4-week follow-up.
Data analysis will be performed with SPSS statistic program (v26). Normality and homoscedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. For comparation between groups Bonferroni will be used. If any confusion factor that not meet requirements to be analysed like a covariable exist, ANCOVA will be used. When p<0.0.5 statistical significant differences will be assumed.
- Conditions
- Older People
- Being tested
- IPC + Exercise protocol, Sham IPC + Exercise protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPC + Exercise protocolOther
The intervention consists of two parts: IPC and endurance training protocol.
IPC: participants will be placed in a supine position and a pneumatic compression cuff (Riester Komprimeter, Jungingen Germany) (96 centimetres long x 13 centimetres wide) will be placed on the proximal part of each lower extremity. Occlusion will then be performed by inflating the cuff to 220 mmHg for 5 minutes, followed by reperfusion to 0 mmHg for 5 minutes. Each session will consist of 3 sets of 5 minutes of ischaemia followed by 5 minutes of reperfusion.
Endurance training protocol: walking 20 min at moderate intensity (i.e. 64- 76 % HRmax, 12-13 Borg Scale) in a circuit designed in an open field, 3 times a week, for 6 weeks.
Sham IPC + Exercise protocolOther
The intervention consists of two parts: sham IPC and endurance training protocol.
Sham IPC: the pressure cuff will be inflated by only 10 mmHg, so that it will act as a placebo.
Endurance training protocol: walking 20 min at moderate intensity (i.e. 64- 76 % HRmax, 12-13 Borg Scale) in a circuit designed in an open field, 3 times a week, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IPC + Exercise protocol group | Experimental | Patients in this group (n=16) will undergo ischaemic preconditioning (IPC) plus an endurance training protocol. Receives: Other: IPC + Exercise protocol |
| Sham IPC + Exercise protocol group | Sham comparator | Patients in this group (n=16) will undergo sham ischaemic preconditioning (IPC) plus an endurance training protocol. Receives: Other: Sham IPC + Exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
"6 minutes walking test" (6MWT)
Measured: 8 minutes
Heart rate variability during walking
Heart rate monitor RS800CX (Polar Electro Oy Kempele, Finland).
Measured: 40 minutes
Secondary outcomes (7)
Lower limb strength: for the assessment of isometric strength
A load cell (CTCS; Mutronic) will be used to measure the strength of the intrinsic and extrinsic muscles of the hip, knee and ankle
Measured: 10 minutes
Muscle mass (sacopenia)
Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).
Measured: 3 minutes
General physical condition
Short Physical Performance Battery
Measured: 5 minutes
Fatigue
Borg scale 20
Measured: 1 minute
Fall risk, agility and dynamic balance
Fall skip
Measured: 3 minutes
Independence in basic activities of daily living (BADL) and instrumental activities of daily living (IADL)
Barthel Index and Lawton and Brody scale, respectively
Measured: 5 minutes
Health-related Quality of Life
EQ-5D-5L
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start12 Nov 2021
- Primary completion12 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Older PeopleStudies 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
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Inglés de la Torre, University of Valencia
- Investigators
- Marta Inglés, Dr, Principal investigator, Univeristy of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144815
- Sponsor's protocol ID
- 151121
- Status last verified
- Jun 2024
- First submitted
- 22 Nov 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
PubMed 3769170Nemoto K, Gen-no H, Masuki S, Okazaki K, Nose H. Effects of high-intensity interval walking training on physical fitness and blood pressure in middle-aged and older people. Mayo Clin Proc. 2007 Jul;82(7):803-11. doi: 10.4065/82.7.803.
PubMed 17605959Ziaaldini MM, Koltai E, Csende Z, Goto S, Boldogh I, Taylor AW, Radak Z. Exercise training increases anabolic and attenuates catabolic and apoptotic processes in aged skeletal muscle of male rats. Exp Gerontol. 2015 Jul;67:9-14. doi: 10.1016/j.exger.2015.04.008. Epub 2015 Apr 21.
PubMed 25910622Munoz-Gomez E, Molla-Casanova S, Sempere-Rubio N, Serra-Ano P, Aguilar-Rodriguez M, Moreno-Segura N, Chulvi-Medrano I, Ingles M. Effectiveness of an endurance exercise programme preceded by ischaemic preconditioning in older people. Geriatr Nurs. 2025 May-Jun;63:442-449. doi: 10.1016/j.gerinurse.2025.03.043. Epub 2025 Apr 18.
PubMed 40252516
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05144815
- Acronym / sponsor ID
- 151121
- Conditions
- Older People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 3 Dec 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.
In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018).
In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, \& Harridge, 2019).
A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, \& Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, \& Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking.
Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.
Detailed description
In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018).
In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, \& Harridge, 2019).
Resistance or endurance training can improve sarcopenia, reduce intramuscular fat accumulation, improve muscle function, among others. Aerobic exercise has been shown to be effective in maintaining muscle mass and strength in older adults is walking (Kubo et al., 2008). In fact, walking can also improve VO2max in older adults when intensities are above ∼40% VO2max (Nemoto, Gen-no, Masuki, Okazaki, \& Nose, 2007). In addition, it has been linked to the prevention of cognitive decline (Maki et al., 2012) and improvements in quality of life (Awick et al., 2015) in older people.
A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, \& Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, \& Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking.
Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.
Therefore, this study is a randomized clinical trial in which three groups of twenty people in each group will participate, with different interventions:
- Experimental group 1: Exercise protocol + IPC.
- Experimental group 2: Exercise protocol + sham IPC.
- Control group. Participants will be evaluated in four moments, at baseline, immediately after the first session, postintervention (after 6-week intervention) and 4-week follow-up.
Data analysis will be performed with SPSS statistic program (v26). Normality and homoscedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. For comparation between groups Bonferroni will be used. If any confusion factor that not meet requirements to be analysed like a covariable exist, ANCOVA will be used. When p<0.0.5 statistical significant differences will be assumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPC + Exercise protocol group | Experimental | Other: IPC + Exercise protocolPatients in this group (n=16) will undergo ischaemic preconditioning (IPC) plus an endurance training protocol. |
| Sham IPC + Exercise protocol group | Sham comparator | Other: Sham IPC + Exercise protocolPatients in this group (n=16) will undergo sham ischaemic preconditioning (IPC) plus an endurance training protocol. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age between 65 -90 years
- Physically inactive (< 150 minutes of physical activity per week).
- Signed informed consent form
Key exclusion criteria (8 listed)
- Institutionalised patients.
- History of stroke in the last 6 months or hospital admission for any reason in the last 3 months.
- Uncontrolled hypertension.
- Medication with anticoagulants.
- Oncological patient with active treatment: chemotherapy or radiotherapy.
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 |
|---|---|---|
| IPC + Exercise protocolThe intervention consists of two parts: IPC and endurance training protocol. IPC: participants will be placed in a supine position and a pneumatic compression cuff (Riester Komprimeter, Jungingen Germany) (96 centimetres long x 13 centimetres wide) will be placed on the proximal part of each lower extremity. Occlusion will then be performed by inflating the cuff to 220 mmHg for 5 minutes, followed by reperfusion to 0 mmHg for 5 minutes. Each session will consist of 3 sets of 5 minutes of ischaemia followed by 5 minutes of reperfusion. Endurance training protocol: walking 20 min at moderate intensity (i.e. 64- 76 % HRmax, 12-13 Borg Scale) in a circuit designed in an open field, 3 times a week, for 6 weeks. | Other | IPC + Exercise protocol group |
| Sham IPC + Exercise protocolThe intervention consists of two parts: sham IPC and endurance training protocol. Sham IPC: the pressure cuff will be inflated by only 10 mmHg, so that it will act as a placebo. Endurance training protocol: walking 20 min at moderate intensity (i.e. 64- 76 % HRmax, 12-13 Borg Scale) in a circuit designed in an open field, 3 times a week, for 6 weeks. | Other | Sham IPC + Exercise protocol group |
Primary outcome
Cardiorespiratory fitness
Time frame: 8 minutes
"6 minutes walking test" (6MWT)
Heart rate variability during walking
Time frame: 40 minutes
Heart rate monitor RS800CX (Polar Electro Oy Kempele, Finland).
7 secondary outcomes
Lower limb strength: for the assessment of isometric strength
Time frame: 10 minutes
Muscle mass (sacopenia)
Time frame: 3 minutes
General physical condition
Time frame: 5 minutes
Fatigue
Time frame: 1 minute
Fall risk, agility and dynamic balance
Time frame: 3 minutes
Independence in basic activities of daily living (BADL) and instrumental activities of daily living (IADL)
Time frame: 5 minutes
Health-related Quality of Life
Time frame: 2 minutes
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 13 Jun 2024.
- Background: PubMed 3769170Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
- Background: PubMed 17605959Nemoto K, Gen-no H, Masuki S, Okazaki K, Nose H. Effects of high-intensity interval walking training on physical fitness and blood pressure in middle-aged and older people. Mayo Clin Proc. 2007 Jul;82(7):803-11. doi: 10.4065/82.7.803.
- Background: PubMed 25910622Ziaaldini MM, Koltai E, Csende Z, Goto S, Boldogh I, Taylor AW, Radak Z. Exercise training increases anabolic and attenuates catabolic and apoptotic processes in aged skeletal muscle of male rats. Exp Gerontol. 2015 Jul;67:9-14. doi: 10.1016/j.exger.2015.04.008. Epub 2015 Apr 21.
- Derived from this study: PubMed 40252516Munoz-Gomez E, Molla-Casanova S, Sempere-Rubio N, Serra-Ano P, Aguilar-Rodriguez M, Moreno-Segura N, Chulvi-Medrano I, Ingles M. Effectiveness of an endurance exercise programme preceded by ischaemic preconditioning in older people. Geriatr Nurs. 2025 May-Jun;63:442-449. doi: 10.1016/j.gerinurse.2025.03.043. Epub 2025 Apr 18.
- 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.
Marta Inglés, Dr principal investigator
Univeristy of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPC + Exercise protocol in people with Older People, run by University of Valencia at 2 sites in Spain.
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 3 inclusion and 8 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 13 Jun 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Cardiorespiratory fitness (time frame: 8 minutes). The study lists 2 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 NCT05144815, which also lists 4 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 13 Jun 2024.