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Agility Training for the Elderly – a one-year randomized controlled intervention

Organizational Data

DRKS-ID:
DRKS00017469
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2019-06-19
Last update in DRKS:
2019-06-19
Registration type:
Retrospective

Acronym/abbreviation of the study

AgilE

URL of the study

No Entry

Brief summary in lay language

Aging is a natural and complex process that implicates for example biological degeneration or changes in the social position of a person and his/her social participation. High age (>60) is closely related to a general reduction of physical performance. Quite often, this leads to a loss of independence of seniors. Although many studies shows that physical activity of seniors is an effective means to counteract aging-related changes, there are still mayor research gaps. Only few longtime studies (>6 months) exist which examine multifaceted changes of healthy seniors after a training intervention. Furthermore, it is striking that multimodal training modes, combining strength-, endurance- and balance training, are solemnly conducted. This exact integral training design is important to counteract the variety of aging-related changes. Current training recommendations (e.g. WHO) view all training (e.g. strength, endurance, balance) modes separately. This leads to unrealistic training volumes for seniors who do not just want to address one training mode. Thus, the aim of the longtime study is to integrally examine the effects of a multimodal, agility-based training. Therefore, 85 retired, independently living men and women older than 60 years are recruited. The participants are enrolled to either the training or the intervention group. The training group trains twice weekly for one year. Training is supervised and conducted in small groups. The control group receives current training recommendations (WHO, 2019) once at the beginning of the one year period and no further treatment. Before and after the one-year training period, a variety of health and performance related parameters are assessed in the training- as well as in the control group. It is expected that the multimodal training of the training group, a opposed to the control group, will induce multiple health and performance related improvements.

Brief summary in scientific language

Aging is a natural and complex process that implicates for example biological degeneration or changes in the social position of a person and his/her social participation. High age (>60) is closely related to a general reduction of physical performance. Frailty is related to reduced strength and/or power, lower cardiovascular function and with the degeneration of neural structures. Quite often, this leads to a loss of independence of seniors. Although many studies show that physical activity is an effective means to counteract aging-related changes, there are still mayor research gaps. Only few longtime studies (>6 months) exist which examine neuromuscular, cardiovascular, cognitive and psychosocial changes of healthy seniors as a response to training. Furthermore, it is striking that multimodal training modes, combining strength-, endurance- and balance training, are solemnly conducted. This exact integral training design is important to counteract the variety of aging-related changes. Current training recommendations (e.g. WHO) view all training (e.g. strength, endurance, balance) modes separately. This leads to unrealistic training volumes for seniors who do not just want to address one training mode. Thus, the aim of the longtime study is to integrally examine the effects of a multimodal, agility-based training. Therefore, a one-year randomized controlled intervention study is conducted. The effectiveness of an agility-based training approach is examined in a two-armed study design. 85 retired, independently living men and women older than 60 years are recruited and are allocated to either the training or the control group. The training group trains twice weekly for one year. Training is supervised and conducted in small groups. The control group receives current training recommendations (WHO, 2019) once at the beginning of the one-year period and no further treatment. Before and after the one-year training period, neuromuscular, cardiovascular, cognitive and psychosocial parameters are assessed in both groups. Improvements with moderate effect size are expected in the training group in all outcome measures. For the control group, no improvements are expected.

Health condition or problem studied

Free text:
Participants are healthy, active seniors, who are facing a higher fall risk due to their age, when compared to younger people
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
multimodal agility-based training intervention (2x/week 1 hour superviesd training in small groups
Arm 2:
control group (once: general training reccommendations for seniors (WHO, 2019) without further intervention)

Endpoints

Primary outcome:
Primary Outcomes are assessed before the intervention period, after 6 months and after the one year intervention: Isometric maximal strength of the leg extensors, leg flexors and the hand are measured with machines with force transducers. Static balance is assessed on a force plate in one-leggend stance and tandem stance. Dynamic balance is assessed on a posturomed with a position sensor after an extermal perturbation. Gait speed is measured in single-, dual-, and triple-task conditions with photoelectrical sensors. Psychosocial parameters are assessed with multiple questionnaires: "Center of Epidemiological Studies Depression Scale", "Perceived Stress Scale", "Insomnia Severity Index", "World Health Organization's Quality of Life Questionnaire". VO2max is measured via a spiroegometry during a step test on a bicyle ergometer. Measurements of VO2max are not conducted at interim measurements after 6 months.
Secondary outcome:
All secondary outcomes are assessed before and after the intervention period: Jump height of the Counter Movement Jump is measured on a force plate. The "Agility Challence for the Elderly" (ACE) is conducted in a gym and time is measured with photoelectrical sensors. A muslce sonography of different leg muscles is done to assess muscle cross sectional area and pennation angle. Central cartoid pulse wave velocity is measured at rest, as well as retinal vessel diameter and echocardiography. During the spiroergometric measurements, an exercise ECG is conducted. Blood samples are taken to analyze several health markers. A 24-houres blood pressure and a 24-houres-ECG measurement are done. To assess cognitive abilities, the "N-back test" and the "Eriksen-Flanker task" are done.

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Deutsche Sporthochschule Köln Köln

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2019-01-07
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
85
Final Sample Size:
85

Inclusion Criteria

Sex:
All
Minimum Age:
60 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
retired; ready to be randomized; able to travel to training site twice a week; independently living

Exclusion Criteria

severe cardiovascular disease (e.g. CHD, cardiac insufficiency); chronic inflammatory disease; pulmonary disease; depression, insulin-dependent diabetes; history of cancer (except completed therapy, symptom free and free of complaints); severe orthopaedic complaints; more than light, age-related osteoporotic changes; BMI>35; severe bone injury in the past 6 months; current strong smoker (>15 pack years); expected time of travel >2 months in the intervention period; more than twice a week structured cardiovascular/neuromuscular training in the past 3 months

Addresses

Primary Sponsor

Deutsche Sporthochschule Köln
Am Sportpark Müngersdorf 6
50933 Köln
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Deutsche Sporthochschule Köln
Univ. Prof. Dr. Lars Donath
Am Sportpark Müngersdorf 6
50933 Köln
Germany
Telephone:
022149827701
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Deutsche Sporthochschule Köln
Mareike Morat
Am Sportpark Müngersdorf 6
50933 Köln
Germany
Telephone:
022149827620
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Deutsche Sporthochschule Köln
Univ. Prof. Dr. Lars Donath
Am Sportpark Müngersdorf 6
50933 Köln
Germany
Telephone:
022149827701
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Deutsche Sporthochschule Köln
Am Sportpark Müngersdorf 6
50933 Köln
Germany
Telephone:
022149827701
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Deutschen Sporthochschule Köln
Am Sportpark Müngersdorf 6
50933 Köln
Germany
Telephone:
(+49)221-49823810
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2018-10-31
Ethics committee number:
131/2018
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-11-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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