Effects of personalized exercise training on physical activity, health-related fitness, sleep quality, and quality of life among middle-aged and older adults with multiple health problems

ISRCTN	ISRCTN44497123
DOI	https://doi.org/10.1186/ISRCTN44497123
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	National Defense Medical Center
Funder	Investigator initiated and funded

Submission date: 29/10/2020
Registration date: 29/10/2020
Last edited: 15/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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)

Contact information

Prof LiChi Chiang
Scientific

School of Nursing
National Defense Medical Center
161 Sec. 6 Mingchuan E. Rd.
Taipei
114
Taiwan

ORCID ID	0000-0002-6383-7495
Phone	+886-02-87923100 ex 18765
Email	lichichiang@gmail.com

Mr YiPang Lo
Public

School of Nursing
National Defense Medical Center
161 Sec. 6 Mingchuan E. Rd.
Taipei
114
Taiwan

ORCID ID	0000-0001-8079-4215
Phone	+886-0988-082940
Email	808010023@mail.ndmctsgh.edu.tw

Study information

Primary study design	Interventional
Study design	Single-center interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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:
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/06/2017

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	All
Target sample size at registration	60
Total final enrolment	43
Key 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).
Key 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
Date of first enrolment	09/11/2016
Date of final enrolment	28/02/2017

Locations

Countries of recruitment

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

Study participating centre

Tri-Service General Hospital

No.325, Sec.2
Cheng-Kung Rd.
Neihu
Taipei
11490
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		25/12/2020	15/03/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/03/2022: Publication reference added.
29/10/2020: Trial’s existence confirmed by Tri-Service General Hospital.