Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People

Older People Clinical Trial

Official title:

Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People: a Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05144815
• Other study ID #: 151121
• Status: Completed
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 30, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age between 65 -90 years

• Physically inactive (< 150 minutes of physical activity per week).

• Signed informed consent form

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Older People

Intervention

Other:
• IPC + Exercise protocol
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 protocol
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.

Locations

Country	Name	City	State
Spain	Elena Muñoz	Valencia	Valencia / València
Spain	Marta Inglés	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

Nemoto 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. — View Citation

Ziaaldini 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness	"6 minutes walking test" (6MWT)	8 minutes
Primary	Heart rate variability during walking	Heart rate monitor RS800CX (Polar Electro Oy Kempele, Finland).	40 minutes
Secondary	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	10 minutes
Secondary	Muscle mass (sacopenia)	Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).	3 minutes
Secondary	General physical condition	Short Physical Performance Battery	5 minutes
Secondary	Fatigue	Borg scale 20	1 minute
Secondary	Fall risk, agility and dynamic balance	Fall skip	3 minutes
Secondary	Independence in basic activities of daily living (BADL) and instrumental activities of daily living (IADL)	Barthel Index and Lawton and Brody scale, respectively	5 minutes
Secondary	Health-related Quality of Life	EQ-5D-5L	2 minutes