- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02415582
Post-Exercise Hypotension in Elderly Hypertensive Men (HPE)
Effects of Different Exercises on Post-Exercise Blood Pressure in Elderly Hypertensive: A Cross-Over Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hypertension has high prevalence and low rate of control, and is a major modifiable risk factor and public health problem. Regular physical exercise is a relevant non-pharmacological option for prevention and treatment of hypertension. Several studies demonstrated a reduction in blood pressure (BP) following different exercise protocols, and the decrease may be the result of the summation of hypotensive effects that occur in the hours following the workout. The reduction resulting from a single exercise session is called post-exercise hypotension (PEH) and has been investigated among hypertensive subjects. However, to achieve clinical relevance the PEH should reach a significant magnitude and the reduction should be sustained for a longer period.
Previous studies showed the positive effects of aerobic exercise on post-exercise hypotension in hypertensive subjects. However, there is lacking evidence regarding the effects of a single session of aerobic and resistance exercise combined, and the duration of its effect in 24 hours blood pressure in elderly hypertensive subjects.
The study is an open, crossover randomized clinical trial, with elderly men allocated to three arms, in a random order:
- Aerobic training session
- Combined resistance training and aerobic session
- Control session
After each exercise session, participants have 60 minutes for recovery, performed in the sitting position, with BP measurements every 5 minutes. In addition, participants have measured BP using 24h ambulatory BP monitoring. At the end of the trial, participants will have completed all three experimental protocols: a non-exercise control session, of sitting rest, and two exercise bouts, one of aerobic exercise and a combined resistance and aerobic exercise, with seven days of washout period among sessions. All experiments will be conducted at the same time of day to account for diurnal BP variation. Before the experimental sessions, participants are enrolled in three pre-intervention tests: a familiarization session, cardiopulmonary exercise testing and one maximum repetition strength test (1RM). The aerobic sessions last for 45 minutes, as well as the resistance exercises, and the session of control.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brasilien, 90035-903
- Hospital de Clínicas de Porto Alegre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Essential hypertension grade 1 - 2 with or without medical treatment:
resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg
Exclusion Criteria:
- Smoking;
- Bone, joint, or muscle problems that could limit the performance of the exercises.
- BMI ≥ 30 kg/m2
- Heart Attack in the last year
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Aerobic exercise
Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.
|
Aerobic exercise on treadmill
|
Eksperimentel: Combined exercises
A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.
|
Combined resistance and aerobic exercise
|
Sham-komparator: Control
Participants do not exercise and remain sitting for 45 minutes
|
45 minutes resting sitting
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ambulatory Blood Pressure Monitoring
Tidsramme: 24 hours
|
Ambulatory blood pressure monitoring following experimental protocols
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Office Blood Pressure
Tidsramme: 1 hour
|
Post exercise blood pressure during 60 minutes after experimental sessions
|
1 hour
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sandra C Fuchs, PhD, Hospital de Clínicas de Porto Alegre
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 130484
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