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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03840330
Other study ID # HIICT-OW/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2015
Est. completion date June 20, 2016

Study information

Verified date March 2019
Source Universidad de Almeria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the adaptations on the functional capacity and cardiovascular in elderly after a physical activity program circuit training. The participants were divided into three groups: Circuit training based on high-intensity interval training group (HIICT), Circuit training at moderate intensity group (MICT) and Control group (CG).


Description:

Three groups of participants (circuit training based on high-intensity interval training, circuit training at moderate intensity and not training group) will enter the study. The intervention will consist of a physical exercise program in day centers.

Intensity progression will be encouraged according to the rate of perceived exertion. Progression of exertion will be "very hard", "extremely hard" and "maximal exertion" for HIT group, and "light", "somewhat hard" and "hard" for group. Assessment will be undertaken at two-time points: baseline and after 16 weeks of exercise training.

Assessment will include VO2 peak, functional capacity, health-related quality of life, cognitive state and daily physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date June 20, 2016
Est. primary completion date February 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria:

1. Having 50 - 90 years old.

2. Not suffering chronic heart, respiratory or joint disease, taking medication or having a deteriorated level of mental health that could interfere in carrying out exercise programs.

3. Having 0 or 1 responses positive in the Physical Activity Readiness Questionnaire (ParQ). Only item 6, related to mild vascular diseases.

4. Being physically independent according to the scales Lawton and Brody, and Katz.

Exclusion Criteria:

1. Having uncontrolled arterial hypertension.

2. Having practiced during the previous 3 months or practicing at present a similar exercise to the one proposed in the study.

3. Attending sessions less than 80%.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental: High-intensity interval training group
16 weeks of High-intensity interval training
Experimental: Moderate-intensity interval training group
16 weeks of Moderate-intensity interval training

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Almeria

References & Publications (4)

Ballesta García I, Rubio Arias JÁ, Ramos Campo DJ, Martínez González-Moro I, Carrasco Poyatos M. High-intensity Interval Training Dosage for Heart Failure and Coronary Artery Disease Cardiac Rehabilitation. A Systematic Review and Meta-analysis. Rev Esp C — View Citation

Guiraud T, Juneau M, Nigam A, Gayda M, Meyer P, Mekary S, Paillard F, Bosquet L. Optimization of high intensity interval exercise in coronary heart disease. Eur J Appl Physiol. 2010 Mar;108(4):733-40. doi: 10.1007/s00421-009-1287-z. — View Citation

Huang SC, Wong MK, Lin PJ, Tsai FC, Fu TC, Wen MS, Kuo CT, Wang JS. Modified high-intensity interval training increases peak cardiac power output in patients with heart failure. Eur J Appl Physiol. 2014 Sep;114(9):1853-62. doi: 10.1007/s00421-014-2913-y. — View Citation

Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate conti — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Analyses change in Self Assessed Physical Activity. Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity. Pre and post after sixteen weeks of intervention.
Primary Analyses changes in maximum oxygen consumption (VO2max). A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2max). Pre and post after sixteen weeks of intervention
Primary Analyses changes in maximum oxygen consumption (VO2max). VO2max was assessed using the 6-Minute Walk Test. The participant should walk the longest distance possible in 6 minutes by walking continuously the 42 metres indicated on the floor. It measures the distance in meters Pre and post after sixteen weeks of intervention
Secondary Analyses changes in heart rate reached in ergometry. Analyses during modified Balke treadmill protocol Pre and post after sixteen weeks of intervention
Secondary Analyses changes in blood pressure reached in ergometry. Analyses during modified Balke treadmill protocol Pre and post after sixteen weeks of intervention
Secondary Analyses changes in maximum speed reached in ergometry. Analyses during modified Balke treadmill protocol Pre and post after sixteen weeks of intervention
Secondary Analyses changes in duration test reached in ergometry. Analyses during modified Balke treadmill protocol Pre and post after sixteen weeks of intervention
Secondary Analyses changes in fat percentage. Fat percentage (%) was assessed using bioimpedance analysis (OMROM BF-306). Pre and post after sixteen weeks of intervention.
Secondary Analyses changes in body mass index (BMI). BMI was assessed using bioimpedance analysis (OMROM BF-306). Pre and post after sixteen weeks of intervention.
Secondary Analyses changes in gait. Gait was assessed using the Timed Up and Go Test. To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record. Pre and post after sixteen weeks of intervention.
Secondary Analyses changes in balance. Balance was assessed using the One Leg Standing Test. This test consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 30 seconds. Pre and post after sixteen weeks of intervention.
Secondary Analyses changes in lower body strength. Lower body strength was assessed using the Sit To Stand 30. For the Sit To Stand 30, the participant consist in measures how many repetition the participant can to stand up and sit down during 30 seconds. Pre and post after sixteen weeks of intervention.
Secondary Analyses changes in upper body strength. Upper body strength was assessed using the Arm Curl Test (30). For this test, the participant consist in measures how many repetition the participant can to curl up and curl down during 30 seconds. Pre and post after sixteen weeks of intervention.
Secondary Analyses changes in maximal handgrip strength. To measure the amount of strength developed by each hand in kg. Pre and post after sixteen weeks of intervention.
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