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 |
- 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
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)
Contact information
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 |
| lichichiang@gmail.com |
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 |
| 808010023@mail.ndmctsgh.edu.tw |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available. |
| 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 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(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: |
| 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 |
| 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 study start date | 01/11/2016 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 43 |
| 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 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
Study participating centre
Cheng-Kung Rd.
Neihu
Taipei
11490
Taiwan
Sponsor information
Hospital/treatment centre
School of Nursing
161 Sec. 6 Mingchuan E. Rd.
Taipei
114
Taiwan
| Phone | +886-0910394366 |
|---|---|
| katty121237@gmail.com | |
| Website | http://www.ndmctsgh.edu.tw/ylbin/changewebkind.asp?info=1858&webkindvirtual=a902 |
"ROR" |
https://ror.org/02bn97g32 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planed publication in a high-impact peer-reviewed journal. |
| 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 |
Editorial Notes
15/03/2022: Publication reference added.
29/10/2020: Trial’s existence confirmed by Tri-Service General Hospital.
