Condition category
Not Applicable
Date applied
29/10/2020
Date assigned
29/10/2020
Last edited
29/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The presence of multimorbidity in middle-aged and older adults, which reduces their physical activity and quality of life, is a global health challenge. We designed a 12-week personalized aerobic exercise training program for middle-aged and older adults with Multimorbidity.

Who can participate?
Adults, over 40 years old, with multimorbidity.

What does the study involve?
Participants were randomized by a research assistant to one of three groups:
1. The intervention group, which received 12 weeks of multidiscipline (including a physician, nurse, and physiotherapist) personalized aerobic exercise training in the rehabilitation department and personalized exercise and medication recommendations at home
2. The comparison group, which received 12 weeks of personalized exercise and medication recommendations at home
3. The control group, which received 12 weeks of usual care. The outcomes were measured at baseline and after 12 weeks in all participants

What are the possible benefits and risks of participating?
Participants may have benefits to increase physical activity and improve fitness, sleep quality and quality of life.
Participants may have risks of some aerobic exercise side effects like excessive sweating, muscle fatigue and soreness etc.

Where is the study run from?
Tri-Service General Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
November 2016 to June 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Yi Pang Lo (winfly1017@hotmail.com)

Trial website

Contact information

Type

Scientific

Primary contact

Prof LiChi Chiang

ORCID ID

http://orcid.org/0000-0002-6383-7495

Contact details

School of Nursing
National Defense Medical Center
161 Sec. 6 Mingchuan E. Rd.
Taipei
114
Taiwan
+886-02-87923100 ex 18765
lichichiang@gmail.com

Type

Public

Additional contact

Mr YiPang Lo

ORCID ID

https://orcid.org/0000-0001-8079-4215

Contact details

School of Nursing
National Defense Medical Center
161 Sec. 6 Mingchuan E. Rd.
Taipei
114
Taiwan
+886-0988-082940
808010023@mail.ndmctsgh.edu.tw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The effect of aerobic exercise training on physical activity, health-related fitness, sleep quality, and quality of life among middle-aged and older adults with multimorbidity

Acronym

Study hypothesis

A 12-week personalized aerobic exercise training program in a rehabilitation center can increase physical activity and improve health-related fitness, sleep quality, and quality of life in middle-aged and older adults with multimorbidity.

Ethics approval

Approved 08/11/2016, Institutional Review Board, Tri-Service General Hospital (No.325, Sec.2, Cheng-Kung Rd. Neihu 11490, Taipei, Taiwan, R.O.C; ), ref:

Study design

Single-center interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Multimorbidity (more than two of the following: hypertension, hyperlipidemia, diabetes, stroke, cancer, heart disease, kidney disease, asthma, chronic obstructive pulmonary disease, osteoporosis, degenerative arthritis, gout, depression, schizophrenia, and bipolar disorder)

Intervention

A randomized controlled trial with three groups was created. All eligible middle-aged and older adults with multimorbidity were randomized by a research assistant to one of three groups:
1. The intervention group, which received 12 weeks of multidiscipline (including a physician, nurse, and physiotherapist) personalized aerobic exercise training in the rehabilitation department and personalized ExRx recommendations at home
2. The comparison group, which received 12 weeks of personalized ExRx recommendations at home
3. The control group, which received 12 weeks of usual care

The randomization sequence was generated using the random number function in Microsoft Excel. Block randomization was designed and stratified by age (<65 years old, ≥65 years old) and gender (male, female). The researchers involved in the data collection were blinded to the group allocation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline and after 12 weeks:
1. Demographic data measured by self report
2. Self-perceived health status measured using the Self-perceived health status scale (Chinese version)
3. Activity measured using the International Physical Activity Questionnaire (IPAQ)-Chinese version short form
4. Objective measurements of health-related physical fitness parameters were performed by a well-trained research assistant:
4.1. Resting heart rate and blood pressure
4.2. Body mass index (BMI) (kg/m²)
4.3. Upper limb grip strength
4.4. Muscular endurance measured using the 30-second chair stand test
4.5. Flexibility measured using the chair sit-and-reach test
4.6. Pulmonary function tests
4.7. Cycle ergometer-based graded exercise test (GXT) using a ramp protocol supervised by a rehabilitation/sports medicine physician to collect data on maximal oxygen uptake (VO2 max), anaerobic threshold (AT), and work, etc., to assess cardiorespiratory fitness

Secondary outcome measures

1. Sleep quality measured using PSQI scale Chinese version at baseline and after 12 weeks
2. Quality of life measured using SF-36 Chinese version at baseline and after 12 weeks

Overall trial start date

01/11/2016

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 40 years old with multimorbidity
2. No cognitive impairment (MMSE > 24)
3. Able to communicate in Mandarin
4. Provided informed consent
5. Current physical activity amount does not meet the WHO recommendations (<150 minutes of moderate-intensity physical activity/week or <75 minutes of vigorous-intensity physical activity/week).

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

60

Total final enrolment

43

Participant exclusion criteria

1. Aerobic exercise training contraindications according to the updated ACSM recommendations for exercise preparticipation health screening as demonstrated by a rehabilitation/sports medicine physician
2. Unable to tolerate moderate to vigorous aerobic exercise training due to impaired neurogenic/musculoskeletal conditions
3. Unable to cooperate with aerobic exercise training
4. Unable to walk without assistance
5. Have been judged to be unsuitable for participation in this study by a rehabilitation/sports medicine physician for other reasons

Recruitment start date

09/11/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Taiwan

Trial participating centre

Tri-Service General Hospital
No.325, Sec.2 Cheng-Kung Rd. Neihu
Taipei
11490
Taiwan

Sponsor information

Organisation

National Defense Medical Center

Sponsor details

School of Nursing
161 Sec. 6 Mingchuan E. Rd.
Taipei
114
Taiwan
+886-0910394366
katty121237@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.ndmctsgh.edu.tw/ylbin/changewebkind.asp?info=1858&webkindvirtual=a902

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planed publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/10/2020: Trial’s existence confirmed by Tri-Service General Hospital.